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

Catalog Number SB534

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Voluntary distributor report 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: conmed received notification from the customer/facility of reported issues with the 3x4 mini endo pocket bag, item # sb534, lot 6251903128 that occurred (b)(6) 2020 at (b)(6) hospital.It was reported only that a piece of plastic fell off and into the patient.The piece was retrieved with no reported impact or injury to the patient and the procedure was successfully completed.Additional information provided indicates the issue occurred during a laparoscopic appendectomy.They realized the issue when the specimen (appendix) was already in the bag and they were pulling the bag out.While taking the bag out under vision, they saw that the small black piece was free from the bag, but do not know when it actually broke off.They were pulling the handle back to close the bag, pulled it and realized the plastic tubing on the bag.They did not realize the piece came from the bag until after the surgery when they saw it on the back table.Other instruments being used at the time of the issue included a davis and geck atraumatic bowel grasper and a 5mm xcel(ethicon) trocar.It was confirmed that there was no impact or injury to the patient and the procedure was successfully completed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 3X4 MINI ENDO POCKET BAG
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEMS INC; 8f-2 no.127; lane 235, pao chiao road; hsin tien, taipai 23144 ; TW 23144
• MDR Report Key: 10176153
• MDR Text Key: 196785247
• Report Number: 3007216334-2020-00262
• 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: Physician
• Type of Report: Initial
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• 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: 6251903128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2020
• Distributor Facility Aware Date: 06/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1