FDA Adverse Event
Malfunction
Summary report: N
RENEW ENDOCUT SCISSOR TIP, DISPOSABLE
MDR report key: 21653178
·
Received March 20, 2025
Report
- Report Number
- 1223422-2025-00008
- Event Type
- Malfunction
- Date Received
- March 20, 2025
- Date of Event
- March 12, 2025
- Report Date
- June 6, 2025
- Manufacturer
- MICROLINE SURGICAL INC
- Product Code
- GEI
- UDI-DI
- 00811099010005
- PMA / PMN Number
- K213127
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AT THIS TIME, MICROLINE SURGICAL, INC. IS AWAITING THE AFFECTED DEVICE BACK FROM THE HOSPITAL SO AN INVESTIGATION CAN BE CONDUCTED. ONCE THE INVESTIGATION IS COMPLETE AND MORE INFORMATION IS AVAILABLE, A FINAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 0
DESPITE REQUESTS FROM MICROLINE SURGICAL, THE DEVICE WAS NEVER RETURNED. SINCE THE ASSOCIATED PRODUCT WAS NOT RETURNED TO MSI FOR INVESTIGATION WITHIN 30+ DAYS, THIS COMPLAINT WAS CLOSED PER PMF-Q2-001.
Description of Event or Problem · 0
DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, THE DEVICE FAILED TO OPEN AND CLOSE DURING A CRITICAL PART OF THE PROCEDURE. THE TIP WAS REMOVED AND REPLACED.
Description of Event or Problem · 0
DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, THE DEVICE FAILED TO OPEN AND CLOSE DURING A CRITICAL PART OF THE PROCEDURE. THE TIP WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1373146 | RENEW ENDOCUT SCISSOR TIP, DISPOSABLE | MANUAL DETACHABLE SURGICAL INSTRUMENT | GEI | MICROLINE SURGICAL INC | 3142 | 00811099010005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female |