MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. BIPOLAR INSERT CEV630-1A 350MM JAWS 3MM; PFM16

Catalog Number CEV630-1A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)

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

Event Date 07/28/2022

Event Type  malfunction  

Manufacturer Narrative

The bipolar insert jaws (cev630-1a) was returned to the manufacturer for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Evaluation of the bipolar insert jaws was unable to conclusively verify the complaint reported by the customer as valid; therefore, an investigation for cause was unable to be performed.The device passed the electrical test.No defect was found.Integra test is performed and validated to assure quality and safety with specific voltage.The hospital tested the device with a higher voltage, which was out of integra¿s specifications.The investigation did not highlight any defect.This complaint was unconfirmed.

Event Description

This is 2 of 3 reports and is linked to mfg report numbers: 3003249645-2022-00039, 3003249645-2022-00041.A facility reported that following an insulation test, before the first use of the bipolar insert jaws (cev630-1a), the unit's dtug detected insulation defect.The insert/device was never sterilized or used on a patient.No patient injury, death or surgical delay has occurred.

• Brand Name: BIPOLAR INSERT CEV630-1A 350MM JAWS 3MM
• 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: 15299615
• MDR Text Key: 305245284
• Report Number: 3003249645-2022-00040
• 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: 03/20/2023

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: Other
• Device Catalogue Number: CEV630-1A
• Device Lot Number: 6270238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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