FDA Adverse Event
Malfunction
Summary report: N
SHEATH, 2.9MM OPERATIVE INNER
MDR report key: 3854334
·
Received June 6, 2014
Report
- Report Number
- 0002936485-2014-00397
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- May 14, 2014
- Report Date
- May 14, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- HIH
- PMA / PMN Number
- K040390
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. NO MISSING PIECES TO THIS DEVICE WERE SEEN. HOWEVER THE VISUAL INSPECTION CONFIRMS DAMAGE TO THE TIP OF THE SHAFT. THE PROBABLE ROOT CAUSE COULD BE USER MISHANDLING. 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 THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE SHEATH IS MISSING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE SHEATH IS MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332911 | SHEATH, 2.9MM OPERATIVE INNER | HYSTEROSCOPE (AND ACCESSORIES) | HIH | STRYKER ENDOSCOPY-SAN JOSE | 1298451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |