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Unassigned RMAs
6
Unique Repair Codes
4
Top Repair Code
R101
Insertion tube fluid invasion
Repair code analysis
| Code | Description | Frequency | Years | FDA / AAMI ST91 guidance |
|---|---|---|---|---|
| R101 | Insertion tube fluid invasion | 3 | 2026 | ST91: perform leak test before manual cleaning; quarantine device. |
| R204 | Angulation wire stretched | 2 | 2026 | Check handling/transport practices; verify angulation per IFU. |
| R330 | Light guide fiber breakage | 1 | 2026 | Verify drying & storage; avoid coiling below IFU radius. |
| R412 | Biopsy channel puncture | 1 | 2026 | Inspect channels with borescope (ST91 §7); risk of bioburden retention. |
Repair Codes
| Code | Description | |
|---|---|---|
| A1 | Failed Leak Test | |
| A2 | Black & White Image | |
| A3 | Damaged Handle | |
| A4 | No Power | |
| A5 | USB Not Detected | |
| A6 | Error Code | |
| A7 | Other |
Unassigned RMAs
| RMA # | P/N | S/N | Repair Code | Description | Date Received | S/N Freq. | Insight | |
|---|---|---|---|---|---|---|---|---|
| RMA-24101 | CF-HQ190L | 2810451 | Angulation wire stretched | 02/11/26 | 4 | Repeat failure (4×) — consider FDA MDR evaluation (21 CFR 803). | ||
| RMA-24102 | GIF-H190 | 2810451 | Insertion tube fluid invasion | 03/12/26 | 4 | Repeat failure (4×) — consider FDA MDR evaluation (21 CFR 803). | ||
| RMA-24103 | CF-HQ190L | 2911032 | Light guide fiber breakage | 04/13/26 | 3 | Repeat failure (3×) — consider FDA MDR evaluation (21 CFR 803). | ||
| RMA-24104 | GIF-H190 | 2810451 | Angulation wire stretched | 05/14/26 | 4 | Repeat failure (4×) — consider FDA MDR evaluation (21 CFR 803). | ||
| RMA-24105 | CF-HQ190L | 2810451 | Biopsy channel puncture | 06/15/26 | 4 | Repeat failure (4×) — consider FDA MDR evaluation (21 CFR 803). | ||
| RMA-24106 | GIF-H190 | 2911032 | Insertion tube fluid invasion | 07/16/26 | 3 | Repeat failure (3×) — consider FDA MDR evaluation (21 CFR 803). |