FDA Adverse Event Injury Summary report: N

ENDO POCKET 7.5X9", 5EA/CS

MDR report key: 15084729 · Received July 22, 2022

Report

Report Number: 3007216334-2022-00009
Event Type: Injury
Date Received: July 22, 2022
Date of Event: June 29, 2022
Report Date: July 22, 2022
Manufacturer: UNIMAX MEDICAL SYSTEMS INC.
Product Code: GCJ
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, UNIMAX MEDICAL SYSTEMS, 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 · 0

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SB979, ENDO POCKET 7.5X9", 5EA/CS, WAS USED DURING A LAP NEPHRECTOMY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿BAG DEPLOYED BUT WOULDN¿T CLOSE. END RESULT HAD TO ENLARGE INCISION TO GET BAG AND SPECIMEN OUT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. HOWEVER, REMOVAL OF THE DEVICE REQUIRED ENLARGING THE INCISION IN THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO INCISION ENLARGEMENT TO REMOVE THE DEVICE AND WILL BE FILED AS A VOLUNTARY DISTRIBUTOR REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
606802	ENDO POCKET 7.5X9", 5EA/CS	LAPAROSCOPE, GENERAL & PLASTIC SURGERY	GCJ	UNIMAX MEDICAL SYSTEMS INC.		6252108186

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other\| R