MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEMS, INC. UNIMAX DETACHABLE POUCH 5X7; SPECIMEN BAG

Catalog Number SB957

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Voluntary distributor report narrative: 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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This is a voluntary distributor report: the customer reported that the unimax sb957, detachable pouch's black plastic pieces that are positioned around the metal ring portion of the introducer fell off while inside the patient.This occurred during a laparoscopic cholecystectomy on (b)(6) 2019.The surgeon was lucky to have seen these before ending the procedure.The pieces were retrieved and there was no patient impact.There was a 5-minute delay in the procedure.This report is being raised on the basis of previous filings for malfunction with potential for injury upon reoccurrence.

• Brand Name: UNIMAX DETACHABLE POUCH 5X7
• Type of Device: SPECIMEN BAG
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEMS, INC.; 8f-2 no. 127; lane 235, pao chiao road; hsin tien,taipai, ; TW
• MDR Report Key: 9531429
• MDR Text Key: 196783580
• Report Number: 3007216334-2019-00434
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SB957
• Device Lot Number: 8251908151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2019
• Distributor Facility Aware Date: 12/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1