FDA Adverse Event
Malfunction
Summary report: N
PREMIUM SURGICLIP II
MDR report key: 6866688
·
Received September 14, 2017
Report
- Report Number
- 1219930-2017-07078
- Event Type
- Malfunction
- Date Received
- September 14, 2017
- Report Date
- October 27, 2017
- Manufacturer
- COVIDIEN LP LLC NORTH HAVEN
- Product Code
- FZP
- PMA / PMN Number
- K954435
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: BRAND NAME: PREMIUM SURGICLIP II, MODEL: 134051, CATALOG: 134051. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, DURING AN OPEN BREAST SURGERY PROCEDURE, WHILE IN THE BREAST TISSUE, THE DEVICE WAS STUCK WHEN CLIPPED. IT DID NOT OPEN AND THEN LOCKED. THEY HAD TO OPEN ANOTHER DEVICE AND FIRE ON BOTH SIDES OF IT AND CUT IT OUT. THE PATIENT IS FINE.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, AS PER THE ADDITIONAL INFORMATION RECEIVED, NO MAJOR DELAYS OR BLOOD LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 646510 | PREMIUM SURGICLIP II | CLIP, IMPLANTABLE | FZP | COVIDIEN LP LLC NORTH HAVEN | 134051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |