MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. INSERT CEV625-1 FENESTRATED 350MM; PFM16

Catalog Number CEV625-1

Device Problem Break (1069)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The 350mm fenestrated insert (cev625-1) was not returned for evaluation; therefore, an investigation for cause was unable to be performed.Device history record (dhr) was not reviewed as lot number information has not been provided.According to the complaint description, the surgeon was burned during the surgery.During use, the user does not touch the insert; therefore, it is determined that the surgeon's burn was not due to this device.The reported issue is not related to this device component, thus this complaint is unconfirmed.

Event Description

This report is 2 of 3 for the 350mm fenestrated insert (cev625-1) component of the forceps used during this event, and is linked to mfg numbers: 3003249645-2024-00011, 3003249645-2024-00016.It was reported that during laparoscopy, the surgeon was burned three times on the fingers while using forceps (coagulation on).The sheath of the forceps was damaged.The device was in contact with a patient; however, no patient injury occurred.The event reportedly led to a 10-minute increase in surgery time.It was later reported that the surgeon did not change the instrument during the procedure between each burn.The burns appeared before the surgeon removed the forceps.When the devices/components were checked in the sterilization department, only the tube was identified as defective.

• Brand Name: INSERT CEV625-1 FENESTRATED 350MM
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18823144
• MDR Text Key: 336733239
• Report Number: 3003249645-2024-00015
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K993655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV625-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• 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