FDA Adverse Event
Injury
Summary report: N
RENEW LAPCLINCH GRASPER FORCEPS TIP REUSABLE
MDR report key: 6709983
·
Received July 13, 2017
Report
- Report Number
- 1223422-2017-00107
- Event Type
- Injury
- Date Received
- July 13, 2017
- Date of Event
- June 16, 2017
- Report Date
- June 21, 2017
- Manufacturer
- MICROLINE SURGICAL, INC.
- Product Code
- GEI
- PMA / PMN Number
- K974066
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED TO MICROLINE INC. A PRODUCT INVESTIGATION IS NOT POSSIBLE.
Description of Event or Problem · 1
DURING A HERNIA REPAIR SURGICAL PROCEDURE, THE SURGEON NOTICED THAT THE HEAT SHRINK FROM THE RENEW LAPCLINCH GRASPER BROKE AT AND FELL INTO THE PATIENT. THE PROCEDURE AND ANESTHESIA TIME WAS EXTENDED BY 10 MINUTES. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 493461 | RENEW LAPCLINCH GRASPER FORCEPS TIP REUSABLE | MANUAL DETACHABLE SURGICAL INSTRUMENTS | GEI | MICROLINE SURGICAL, INC. | 3251 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |