FDA Adverse Event Malfunction Summary report: N

UNKNOWN STAPLING DEVICE

MDR report key: 11223577 · Received January 25, 2021

Report

Report Number
1219930-2021-00353
Event Type
Malfunction
Date Received
January 25, 2021
Report Date
January 25, 2021
Manufacturer
COVIDIEN LP LLC NORTH HAVEN
Product Code
GDW
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
KS
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE ABLE TO BE "FIE" HOWEVER IT STOPPED HALFWAY AND PARTIALLY FIRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
118343 UNKNOWN STAPLING DEVICE STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN STAPLING DEVICE

Patients

Seq Age Sex Outcome Treatment
1