MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEMS, INC. MINI ENDO POCKET BAG 3X4; SPECIMEN BAG

Catalog Number SB534

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer 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

Voluntary distributor report: the conmed representative reported on behalf of the facility that the unimax, sb534, specimen bag's "introducer has a black plastic tip that is at the distal end of the bag.During the procedure a (b)(6) 2019, this black tip broke twice and fell off into the patient.The tip was retrieved.No patient injury.The procedure was completed with no delay.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: MINI ENDO POCKET BAG 3X4
• Type of Device: SPECIMEN BAG
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEMS, INC.; 8f-2 no. 127; lane 235, pao chiao road; hsin tien,taipai, ; TW
• MDR Report Key: 8864025
• MDR Text Key: 153721291
• Report Number: 3007216334-2019-00280
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8251901160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2019
• Distributor Facility Aware Date: 07/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1