MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. TUBE CEV649-5B DIA 5MM 350MM; PFM16

Catalog Number CEV649-5B

Device Problem Break (1069)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The dia 5mm 350mm tube (cev649-5b) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the returned tube found that the failed electrical test.The electrical insulation was damaged at around 4cm from distal end of the tube.However, the tube was not in contact with the hand of the surgeon during the use.Root cause analysis: it was determined that the surgeon's burn was probably due to the use of an uninsulated handle with damaged gloves or gloves with degraded isolating properties.Details of the handle reportedly used during this event will be captured under mfg number 3003249645-2024-00016.

Event Description

This report is 1 of 3 for the dia 5mm 350mm tube (cev649-5b) component of the forceps used during this event, and is linked to mfg numbers: 3003249645-2024-00015, 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: TUBE CEV649-5B DIA 5MM 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: 18823140
• MDR Text Key: 336732711
• Report Number: 3003249645-2024-00011
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV649-5B
• Device Lot Number: 120302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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