MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEMS INC. DETACHABLE POUCH 3X6" 5EA/BOX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number SB936

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The sales representative reported on behalf of the customer that the device, sb936, detachable pouch 3x6" 5ea/box was being used during a cholecystectomy on (b)(6) 22 and "during the colecisty surgery the bag breaks¿.There was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.After further assessment it was found ¿the procedure took more time due to this issue.Minutes n/a.The gall bladder was in the bag when it brokes, fortunately the gall bladder doesn¿t broke and the doctor was able to put out the gall bladder undamaged from the body.¿ the bag did not fragment and the procedure was completed.The patient is "good".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence and will be filed as a voluntary distributor report.

• Brand Name: DETACHABLE POUCH 3X6" 5EA/BOX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEMS INC.; no.37, sec. 2, ligong 1st rd.; pao chiao road hsin tien; taipai ; TW
• MDR Report Key: 14989274
• MDR Text Key: 295770758
• Report Number: 3007216334-2022-00007
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SB936
• Device Lot Number: 6252012072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2022
• Distributor Facility Aware Date: 06/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2022
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic