FDA Adverse Event
Malfunction
Summary report: N
STRYKER WIRE COLLET
MDR report key: 20758082
·
Received November 21, 2024
Report
- Report Number
- MW5162792
- Event Type
- Malfunction
- Date Received
- November 21, 2024
- Date of Event
- November 14, 2024
- Report Date
- November 19, 2024
- Manufacturer
- STRYKER ENDOSCOPY
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
UPON BORESCOPE INSPECTION OF A NEW, REPLACEMENT SURGICAL COLLET (MANUFACTURER: STRYKER PART NUMBER 4100-062-000, SERIAL NUMBER: (B)(6), RUST WAS NOTED. PRODUCT WAS SEQUESTERED. THE MANUFACTURER'S REPRESENTATIVE WAS NOTIFIED VIA E-MAIL, WITH PICTURES OF NON-CONFORMITIES ATTACHED. REPLACEMENT PART REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2256827 | STRYKER WIRE COLLET | ARTHROSCOPE | HRX | STRYKER ENDOSCOPY | 4100-062-000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |