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

Model Number	SB534
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Voluntary distributor report: on behalf of the customer, the conmed representative reported issues with the 3x4 mini endo pocket bag, item sb534, lot 6251903128.It was reported only that a piece of plastic breaks off and falls into the patient when the bag is being deployed.Additional information provided indicates the issue occurred on (b)(6) 2020 during a robotic cholecystectomy.While the specimen was being removed through the incision, the plastic piece splintered either during or just after the removal of the specimen.It was clarified that the piece in question never broke or fell inside the patient.There was no impact or injury to the patient, no indication of the specimen falling out or fragmentation of the bag.The procedure was successfully completed and the device in question was discarded.The size of the trocar is unknown and standard robotic instruments like a grasper were being used at the time.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 3X4 MINI ENDO POCKET BAG
• Common Device Name: 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: 10153859
• Report Number: 3007216334-2020-00246
• Device Sequence Number: 2050982
• Product Code: GCJ
• UDI-Device Identifier: 04714127860664
• UDI-Public: (01)04714127860664(17)240505(10)6251903128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2020
• Report Date (Section F): 06/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2024
• Device Model Number: SB534
• Device Catalogue Number: SB534
• Device Lot Number: 6251903128
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/15/2020