FDA Adverse Event
Injury
Summary report: N
PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
MDR report key: 2003667
·
Received February 23, 2011
Report
- Report Number
- 2183620-2011-00020
- Event Type
- Injury
- Date Received
- February 23, 2011
- Report Date
- February 10, 2011
- Manufacturer
- SYNOVIS SURGICAL INNOVATIONS
- Product Code
- DXZ
- PMA / PMN Number
- K040415
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. (B)(4).
Description of Event or Problem · 1
AN ARTICLE REPORTED THAT DURING 121 LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) PROCEDURES, PERI-STRIPS DRY STAPLE LINE REINFORCEMENT WAS USED TO REINFORCE THE GASTRIC STAPLE LINE. IT WAS REPORTED THAT ONE PATIENT SUFFERED A POST-OPERATIVE STRICTURE WHICH REQUIRED ENDOSCOPIC DILATION. NO FURTHER DETAILS WERE PROVIDED. MEDICAL DEVICE REPORT SUBMITTED FOR THE SAME ARTICLE IS MANUFACTURER REPROT NUMBER: 2183620-2011-0019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERI-STRIPS DRY STAPLE LINE REINFORCEMENT | STAPLE LINE BUTTRESS | DXZ | SYNOVIS SURGICAL INNOVATIONS | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |