MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV133 BIPOLAR 350MM LRG BOTELLA; PFM16

Catalog Number CEV133

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

Product or objective evidence was returned and the evaluation.The black plastic part was burnt between the connectors.The device was difficult to use.After lubrication, the device worked easily.Device history record (dhr) was reviewed and no anomalies that could be associated with the complaint were observed.The complaint was verified as valid.The device did not work because there was an electrical continuity problem due to the burn of the plastic part.The burn of the plastic part was the consequence of the formation of an electric arc, probably due to the presence of humidity in the connection zone (cable not dried / blood / tissues).It can come from a defect of cleaning or of drying of the instrument despite of recommendations in the instructions for use (ifu).Moreover, the device jams due to a lack of lubrication.

Event Description

An electrical issue was reported on the cev133 forceps cev133 bipolar 350mm lrg botella.The forceps worked intermittently.They changed the cable but they still had the issue so they changed the forceps and it worked.The product was in contact with the patient.There was no patient injury.It was unknown if the event lead to a significant increase in surgery time.

• Brand Name: FORCEPS CEV133 BIPOLAR 350MM LRG BOTELLA
• 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 ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10247897
• MDR Text Key: 202206256
• Report Number: 2523190-2020-00072
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV133
• Device Lot Number: 4012323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• 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