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U.S. Department of Health and Human Services

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

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UNIMAX MEDICAL SYSTEMS, INC. UNIMAX DETACHABLE POUCH 5X7 SPECIMEN BAG Back to Search Results
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.

 
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Brand NameUNIMAX DETACHABLE POUCH 5X7
Type of DeviceSPECIMEN BAG
Manufacturer (Section D)
UNIMAX MEDICAL SYSTEMS, INC.
8f-2 no. 127
lane 235, pao chiao road
hsin tien,taipai,
TW
MDR Report Key9531429
MDR Text Key196783580
Report Number3007216334-2019-00434
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSB957
Device LOT Number8251908151
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/30/2019
Distributor Facility Aware Date12/06/2019
Event Location Hospital
Date Report TO Manufacturer12/17/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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