MAUDE Adverse Event Report: AB MEDICA SAS OUTER TUBE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number LIL-TU-31

Device Problem Energy Output Problem (1431)

Patient Problem Burn(s) (1757)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

The second product code for this device is gei.The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device, lil-tu-31, was being used during an unknown type of procedure on (b)(6) 2020 when it was reported that energy breached the shaft of the instrument and caused a minor burn at the port site of the cannula.The patient sustained and unknown degree of burn.The procedure had been completed successfully and the doctor stated that the patient was "okay".Further assessment information has been requested; however, at this time there has been no further information reported to the facility's sales representative who has attempted to gain the information.This report is being raised on the basis of injury due to an unknown degree of burn to the patient.

Manufacturer Narrative

To date, the reported device has not been returned to conmed for evaluation.Should the device be returned an evaluation will be performed.Upon completion of the complaint investigation a supplemental and final report will be filed.Otherwise this filing will stand as the final report.The manufacturing documents from the device history record could not be requested due to the lot number of the device being unknown.A device lot number history could not be conducted due to the lot number of the device being unknown.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: OUTER TUBE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): AB MEDICA SAS; au capital de 300000; les petites quarterees; mer sur cher, 18100 ; FR 18100
• MDR Report Key: 9865108
• MDR Text Key: 186724093
• Report Number: 1320894-2020-00138
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K140101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LIL-TU-31
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other