FDA Adverse Event
Malfunction
Summary report: N
RENEW
MDR report key: 9156833
·
Received October 4, 2019
Report
- Report Number
- 9156833
- Event Type
- Malfunction
- Date Received
- October 4, 2019
- Date of Event
- September 6, 2019
- Report Date
- September 6, 2019
- Manufacturer
- MICROLINE SURGICAL, INC.
- Product Code
- OTJ
- UDI-DI
- 08719324463171
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 0
MICROLINE SURGICAL ENDOCUT SCISSOR TIP WAS REPORTED TO BE DULL BY DOCTOR AND REPORTED TO BE MAKING A CLICKING SOUND WHEN OPERATED BY STAFF. WHEN THIS WAS NOTICED A NEW SCISSOR TIP WAS GIVEN THAT WORKED FINE.
Description of Event or Problem · 1
MICROLINE SURGICAL ENDOCUT SCISSOR TIP WAS REPORTED TO BE DULL BY DOCTOR AND REPORTED TO BE MAKING A CLICKING SOUND WHEN OPERATED BY STAFF. WHEN THIS WAS NOTICED A NEW SCISSOR TIP WAS GIVEN THAT WORKED FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 948983 | RENEW | ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES | OTJ | MICROLINE SURGICAL, INC. | 3142 | 00147449 | 08719324463171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |