MAUDE Adverse Event Report: AB MEDICA SAS MICROLAP CRVD SCISSORS INSERT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number C-LIL-IP-2SC-31ST

Device Problem Product Quality Problem (1506)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation by the service center per the inspection procedure found that the device passed all test criteria including the insulation test.A device history record review could not be conducted since the serial number of the device was not available.A service history review could not be conducted since the serial number of the device was not available.Per the instructions for use, the user is advised the following: cautions: to avoid burns: always keep the working end of the product in the user's field of vision whenever rf power is activated.Prior to each use, visually inspect the product for damage or surface changes to the insulation.When using accessories for endoscopy or laparoscopy, deactivate the automatic switch-on mode of the rf device.Warnings: risk of injury when using the product beyond the field of view.Apply the product only under visual control.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the c-lil-ip-2sc-31st device was being used in a bilateral salpingectomy on (b)(6) 2019 when a 1st degree burn was caused to the patient' bowel while the device (scissors) were touching the diathermy device.A secondary incision was required for the surgeon to be able to envelope/pull together the burned tissue for suturing.This caused a 15-minute delay in the procedure which was then completed successfully.It was reported that there was no injury to the patient.This report is being raised on the basis of injury due to secondary incision required for medical intervention.

• Brand Name: MICROLAP CRVD SCISSORS INSERT
• 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
• Manufacturer (Section G): AB MEDICA SAS; au capital de 300000; les petites quarterees; mer sur cher, 18100 ; FR 18100
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 8934587
• MDR Text Key: 159518457
• Report Number: 1320894-2019-00291
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-LIL-IP-2SC-31ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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