FDA Adverse Event
Malfunction
Summary report: N
10MM, 33CM RATCHETING HANDLE
MDR report key: 3143577
·
Received June 3, 2013
Report
- Report Number
- 0002936485-2013-00248
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 21, 2013
- Report Date
- May 21, 2013
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- KOG
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. CRACKED INSULATION WAS SEEN NEAR THE DISTAL END. THE PROBABLE ROOT CAUSES ARE USER MISUSE, IMPROPER STERILIZATION METHODS, AND/OR NORMAL WEAR. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT WAS CRACKED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT WAS CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244551 | 10MM, 33CM RATCHETING HANDLE | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | ¿0840071D¿ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |