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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEMS, INC. ENDO POCKET 7.5X9" LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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UNIMAX MEDICAL SYSTEMS, INC. ENDO POCKET 7.5X9" LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number SB979
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2020
Event Type  Injury  
Manufacturer Narrative

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.

 
Event Description

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.

 
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Brand NameENDO POCKET 7.5X9"
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
UNIMAX MEDICAL SYSTEMS, INC.
8f-2 no. 127
lane 235, pao chioa road
hsin tien, taipai
TW
MDR Report Key10470996
MDR Text Key204941950
Report Number3007216334-2020-00376
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeTD
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSB979
Device LOT Number8251902166
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/31/2020
Distributor Facility Aware Date08/06/2020
Event Location Other
Date Report TO Manufacturer08/13/2020
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?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/31/2020 Patient Sequence Number: 1
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