FDA Adverse Event
Malfunction
Summary report: N
REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
MDR report key: 6517393
·
Received April 24, 2017
Report
- Report Number
- 1223422-2017-00055
- Event Type
- Malfunction
- Date Received
- April 24, 2017
- Date of Event
- December 7, 2017
- Report Date
- April 24, 2017
- Manufacturer
- MICROLINE SURGICAL, INC
- Product Code
- FZP
- PMA / PMN Number
- K013695
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND AN INVESTIGATION IS PENDING (NOT COMPLETED) AT THE TIME OF THIS MDR SUBMISSION. (B)(4).
Description of Event or Problem · 1
DURING A SLEEVE GASTRECTOMY/BY PASS/CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LAST CLIP IN THE CLIP CARTRIDGE OF THE ML-10 CLIP APPLIER, DID NOT RELEASE. ANOTHER CLIP CARTRIDGE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE AND THE ANESTHESIA TIME WAS EXTENDED BY TEN (10) MINUTES. THERE WAS NO HARM TO THE PATIENT. THERE ARE FIVE DEVICES ASSOCIATED TO THIS INCIDENT INCLUDING THIS MDR 1223422-2017-00055. MDR REF# 1223422-2017-00052, MDR REF# 1223422-2017-00053, MDR REF# 1223422-2017-00054, MDR REF# 1223422-2017-00056.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299006 | REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS | CLIPS, IMPLANTABLE | FZP | MICROLINE SURGICAL, INC | 1122 | 00130529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |