MAUDE Adverse Event Report: AB MEDICA SAS MICROLAP INSULTATED OUTER TUBE; LAPAROSCOPIC ELECTRODE

Catalog Number C-LIL-TU-31

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to the private label manufacturer for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.

Event Description

The customer reported the surgeon noticed a peculiar light from within the abdomen of the patient and asked the assistant to watch the patient's belly whilst she used thec-lil-tu-31, micro lap bent scissor, with the monopolar diathermy attached.She noticed no strange light as the device was being used for the first 5 or 6 electrosurgical uses.After some use she saw a blue light from within the peritoneal cavity.The assistant advised the surgeon to stop using the instrument and remove it for inspection.Upon inspection the insulation of the micro lap scissors was damaged, and metal could be seen.It appears the damaged insulation caused a minor burn to the patient's fallopian tube.The insulating tubing was changed, and the procedure continued as planned.The surgeon concluded it was a minor burn and no major damage was done, nor would it require any additional treatment.There was a reported 2-minute delay in surgery.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device was visually inspected by a conmed lab technician.One c-lil-tu-31 was received in opened unoriginal packaging.The reported catalog and lot numbers were verified.Visual inspection of the device found that the insulation on the shaft was damaged approximately 5.5 inches from the distal end.The peculiar light referenced in the complaint is likely arcing "form" the exposed area of the shaft where the insulation has been compromised.Request for the evaluation have been sent to the manufacturer.Should the evaluation be received a follow up report will be filed.Otherwise this filing will stand as the final report.A two-year review of complaint history revealed there has been a total of one (1) complaint, regarding one (1) device, for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.The reported rate of failure for this device and failure mode: (b)(4).Per the instructions for use, the user is advised the following: inspect the product for loose, bent, broken, cracked, worn or fractured components prior to each use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MICROLAP INSULTATED OUTER TUBE
• Type of Device: LAPAROSCOPIC ELECTRODE
• Manufacturer (Section D): AB MEDICA SAS; au capital de 300000; les petites quarterees; mer sur cher, 18100 ; FR 18100
• Manufacturer (Section G): AB MEDICA SAS; au capital de 300000; les petites quarterees; mer sur cher, 18100 ; FR 18100
• Manufacturer Contact: melanie hansen ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8134252
• MDR Text Key: 129581188
• Report Number: 1320894-2018-00260
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

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: C-LIL-TU-31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16 YR