FDA Adverse Event
Malfunction
Summary report: N
22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014
MDR report key: 4090355
·
Received September 15, 2014
Report
- Report Number
- 0002936485-2014-00712
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- August 18, 2014
- Report Date
- August 25, 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 HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. VISUAL INSPECTION : THE 22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014 WAS RECEIVED WITH MISSING LOOP WHICH WAS NOT SHIPPED WITH THE UNIT. PROBABLE ROOT CAUSE COULD BE USER ERROR OR USER MISHANDLING. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ELECTRIC LOOP BROKE OFF INTO THE PATIENT AND WAS RETRIEVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ELECTRIC LOOP BROKE OFF INTO THE PATIENT AND WAS RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568507 | 22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014 | HYSTEROSCOPE (AND ACCESSORIES) | HIH | STRYKER ENDOSCOPY-SAN JOSE | STRIL03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |