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

Catalog Number SB534

Device Problem Material Integrity Problem (2978)

Patient Problem Missing Value Reason (3192)

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.

Event Description

This is a voluntary distributor report.The sb534 device was received at conmed and evaluated.Evaluation of the device found a tear in the specimen bag.No information regarding the facility, patient or procedure is available.This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: MINI ENDO POCKET BAG 3X4
• Type of Device: MINI ENDO POCKET BAG 3X4
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEMS, INC.; 8f-2, no. 127; lane 235, pao chiao road; hsin tien city, taipei ; TW
• MDR Report Key: 7684834
• MDR Text Key: 113871212
• Report Number: 3007216334-2018-00176
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 07/12/2018,07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SB534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2018
• Distributor Facility Aware Date: 07/05/2018
• Date Report to Manufacturer: 07/12/2018
• Type of Device Usage: N
• Patient Sequence Number: 1