FDA Adverse Event Injury Summary report: N

ENDO POCKET 7.5X 9"

MDR report key: 7740864 · Received August 1, 2018

Report

Report Number: 3007305485-2018-00179
Event Type: Injury
Date Received: August 1, 2018
Date of Event: July 4, 2018
Report Date: August 1, 2018
Manufacturer: UNIMAX MEDICAL SYSTEMS, INC.
Product Code: GCJ
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER UNIMAX MEDICAL SYSTEMS, INC. IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH CONMED CORPORATION.

Description of Event or Problem · 1

THIS IS A VOLUNTARY DISTRIBUTOR REPORT THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC DONOR NEPHRECTOMY, WHILE REMOVING THE KIDNEY, THE SB979 BAG BROKE DURING THE EXTRACTION PHASE. THE SURGEON HAD TO EXTEND THE INCISION TO GET THE KIDNEY OUT. THERE WAS A 10 MINUTE DELAY REPORTED BUT NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION REGARDING THE CURRENT PATIENT STATUS OR PROCEDURE WAS PROVIDED. DUE TO THE INCISION NEEDING TO BE WIDENED TO COMPLETE THE PROCEDURE, THIS INCIDENT IS RAISED BASED ON A PATIENT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
580742	ENDO POCKET 7.5X 9"	SPECIMEN BAG	GCJ	UNIMAX MEDICAL SYSTEMS, INC.		8251710332

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other