FDA Adverse Event Injury Summary report: N

ENDO POCKET 7.5X9"

MDR report key: 10470996 · Received August 31, 2020

Report

Report Number: 3007216334-2020-00376
Event Type: Injury
Date Received: August 31, 2020
Date of Event: July 13, 2020
Report Date: August 31, 2020
Manufacturer: UNIMAX MEDICAL SYSTEMS, INC.
Product Code: GCJ
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: TD
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, UNIMAX MEDICAL SYSTEM, IS RESPONSIBLE FOR PERFORMING THE EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem · 1

THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE SB979 WAS BEING USED DURING A NEPHRECTOMY PROCEDURE ON (B)(6) 2020. THE DISTRIBUTOR REPORTED "THIS SPECIMEN POUCH BURST IN THE DURATION OF A KIDNEY REMOVAL". THIS CAUSED A 25-30 MINUTE DELAY IN THE PROCEDURE. BY WAY OF ENLARGING THE INCISION THE USER WAS ABLE TO RETRIEVE THE PIECES OF THE DEVICE. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE USER OR THE PATIENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION DUE TO THIS EVENT. THE OEM, UNIMAX MEDICAL SYSTEMS, HAS BEEN NOTIFIED OF THIS EVENT AND NO RESPONSE HAS BEEN RECEIVED. THE OEM HAS REPORTING RESPONSIBILITY FOR THIS EVENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE ENLARGEMENT OF THE INCISION THAT WAS REQUIRED TO RETRIEVE THE COMPONENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
938458	ENDO POCKET 7.5X9"	LAPAROSCOPE, GENERAL & PLASTIC SURGERY	GCJ	UNIMAX MEDICAL SYSTEMS, INC.		8251902166

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Other