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

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.

• Brand Name: MINI ENDO POCKET BAG 3X4 10/SC
• Type of Device: LAPAROSCOPE, 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 Key: 10493838
• MDR Text Key: 206528071
• Report Number: 3007216334-2020-00374
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SB534
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2020
• Distributor Facility Aware Date: 08/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1