MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK CEV390C DIA 3.5MM 330MM MONOPOLAR; PFM16

Catalog Number CEV390C

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2021

Event Type  malfunction  

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

A facility reported that during setup, it was observed that sheath of the hook cev390c was stripped at the level of the handle after three uses.The device was not in contact with the patient and the event did not lead to delay or increase of surgery time.There was no harm to user or patient.

Event Description

N/a.

Manufacturer Narrative

Device history record (dhr): the dhr was reviewed and no anomalies related to the reported failure was observed.Failure analysis - the investigation of the returned device verified the complaint as valid.The insulation sheath is shortened near the handle.Moreover, there is a clearance between the tube and the handle at the laser welding.However, the dimensions of the 2 components are compliant with the specifications.Root cause - the most probable cause of this issue is a defect in the sheathing process.Moreover, this kind of material is fragile and can have a stability defect.A replacement of the sheathing by a coating process is under study.The device is fragile at the laser weld because there is too much clearance between the two parts: the dimensions of the tube d3 is in the lower tolerance and the other part is in the higher tolerance.The dimensions of the 2 parts are incompatible to perform a proper welding, it's a human error during this operation.

• Brand Name: HOOK CEV390C DIA 3.5MM 330MM MONOPOLAR
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 11242570
• MDR Text Key: 229334037
• Report Number: 2523190-2021-00011
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV390C
• Device Lot Number: 4975066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1