MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK CEV2295A 3PK N5 FOR HOOK HANDLE; PFM16

Catalog Number CEV2295A

Device Problem Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that during surgery, the hook cev2295a melted and the plastic part came off.It is unknown if there was patient injury or surgical delay.Additional information has been requested.

Manufacturer Narrative

Additional information received as follows: the device was in contact with patient and the blue plastic part of the hook cev229a melted and made filaments in the patient's stomach.The surgeon had to remove them manually.The event led to increased surgery time of 30 minutes; however no patient injury occurred.Device history record: dhr was reviewed and no anomalies that could be associated with the complaint were observed.The hook cev229a was returned for evaluation: failure analysis - the coating is damaged near the hook and seems to be melted.The metal part became black.No event has been registered concerning coating process during the manufacturing of the hook.Root cause - this reported event is probably due to the use of a too important voltage or a prolonged activation of the device.

• Brand Name: HOOK CEV2295A 3PK N5 FOR HOOK HANDLE
• 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: 11290772
• MDR Text Key: 234201083
• Report Number: 2523190-2021-00027
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV2295A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1