MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. TUBE CEV6795B DIA 5MM 350MM; PFM16

Catalog Number CEV6795B

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This report is 2 of 3, for the dia 5mm 350mm tube (cev6795b) component of the forceps used during this event.This report is related to mfg report number 3003249645-2023-00030 and 3003249645-2023-00032.It was reported that the staff heard a crackling during the use of the forceps.Towards the end of the procedure, the surgeon stated that his thumb gets hot when he uses the bipolar forceps.He noticed a superficial burn on his thumb when removing the gloves.It was reported that the device was in contact with a patient; however, no patient injury was recorded.A 10-minute delay in procedure occurred and another forceps was used.

Manufacturer Narrative

The suspected dia 5mm 350mm tube ((b)(4)) was returned for evaluation: failure analysis: evaluation of the tube (cev6795b) was unable to conclusively verify the complaint reported by the customer as valid.Therefore, an investigation for cause was unable to be performed.The received tube was compliant with the specifications, no defect was found.This complaint was not related to this device.Root cause analysis: the investigation did not highlight any defect; thus, this complaint was unconfirmed.

Event Description

N/a.

• Brand Name: TUBE CEV6795B 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: 18108176
• MDR Text Key: 327868318
• Report Number: 3003249645-2023-00031
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K210942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV6795B
• Device Lot Number: 1329244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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 Sex: Male