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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEMS, INC. MINI ENDO POCKET BAG 3X4 10/SC LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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UNIMAX MEDICAL SYSTEMS, INC. MINI ENDO POCKET BAG 3X4 10/SC LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number SB534
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/12/2020
Event Type  Malfunction  
Manufacturer Narrative

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.

 
Event Description

The sales representative reported on behalf of the customer that the sb534 was being used during a gyn urogyn on (b)(6) 2020 when "the black plastic piece came off during use in the patient. Retrieved". There was no report of a delay to the procedure and the procedure was completed as planned with another sb534 device. There was no report of injury to the patient or the user and there was no medical intervention or hospitalization due to this event. The oem of the device, unimax medical system, has been advised of this event. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

 
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Brand NameMINI ENDO POCKET BAG 3X4 10/SC
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 Key10493838
MDR Text Key206528071
Report Number3007216334-2020-00374
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 09/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSB534
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/04/2020
Distributor Facility Aware Date08/13/2020
Event Location Hospital
Date Report TO Manufacturer08/21/2020
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

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