MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CP390-8 MONOPOLAR 160MM W/TEETH; PFM11

Catalog Number CP390-8

Device Problem Failure to Conduct (1114)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that during surgery, the conduction of the 160mm monopolar forceps w/teeth (cp390-8) occurred intermittently or not at all despite changing the cable, which worked well with another forceps.It is suspected that the issue comes from the sheath at the proximal end being too thick.Reportedly, the connection problem occurred following the change of sheathing on the facility's monopolar plugs.It was reported that there was an increase in surgery time of 10 minutes.There was no consequence for patient.A replacement device was used from their stock.

Manufacturer Narrative

E1: customer primary email: (b)(6).The 160mm monopolar forceps w/teeth (cp390-8) was returned for evaluation: the device history review (dhr) for lot no.5093452 was reviewed and no anomalies that could be associated with the reported complaint were observed.Failure analysis: evaluation of the monopolar forceps verified the complaint reported by the customer as valid.The thickness of the coating on proximal part was greater than specifications which probably results in a poor connection between the cable and the monopolar connector.There was no other coating defect.The forceps passed the electrical tests.Root cause analysis: it was determined that the cause of this thickness defect is a defect of coating process.

Manufacturer Narrative

Updated fields: g3, g6, h2, h10, h11.Corrected field: g4 - 510(k).

Event Description

N/a.

• Brand Name: FORCEPS CP390-8 MONOPOLAR 160MM W/TEETH
• Type of Device: PFM11
• 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: 18253088
• MDR Text Key: 330666200
• Report Number: 3003249645-2023-00035
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CP390-8
• Device Lot Number: 5093452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2020
• 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