MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEMS, INC. DETACHABLE POUCH 5X7; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number SB957

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

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

Voluntary distributor report the sales representative reported on behalf of the customer that the sb957 was being used on (b)(6) 2020 during a bariatric surgery when small, plastic piece fell off inside the patient and was retrieved using laparoscopic graspers.This caused a 10-minute delay in the procedure.However, the procedure was completed as planned.There was no injury to the patient and no medical intervention or hospitalization.The patient is reported as current status of "good".This is an oem device owned by unimax medical system.This will be reported as a voluntary distributor report.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: DETACHABLE POUCH 5X7
• 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: 10271399
• MDR Text Key: 204942727
• Report Number: 3007216334-2020-00296
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2020
• Distributor Facility Aware Date: 06/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1