MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HANDLE CEV6385R DIA 5MM STR MONOPOLAR; PFM16

Catalog Number CEV6385R

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg numbers; 2523190-2019-00150 and 2523190-2019-00152.

Event Description

A facility reported that during a laparoscopic surgery for a bilateral inguinal hernia, the articulated jaw of the needle holder broke in patient's abdomen.The broken piece was retrieved from the patient¿s abdomen and another needle holder was used to finish the procedure.There was no reported consequence for the patient and the surgery delay was stated to be less than 30 minutes.

Manufacturer Narrative

Additional information received on 03jan2020 stated that a 78-year-old female had a cholecystectomy by laparoscopy procedure and at the end of the surgery, had a third-degree burn under the mammary region, 1 cm with 5 mm diameter.The treatment that was provided was a paraffin gauze dressing.Product was returned for evaluation.Dhr for lot no.200902mf1 reviewed and no anomalies that could be associated with the complaint were observed.The device is compliant with the specifications.The investigation did not highlight any defect.The reported event is probably due to an unintentional contact between the unisolated handle and the patient, despite of the recommendations of instructions for use.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted donna engleman, director of regulatory programs, office of product evaluation and quality and (b)(6), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

Event Description

N/a.

• Brand Name: HANDLE CEV6385R DIA 5MM STR 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: 10276586
• MDR Text Key: 203514630
• Report Number: 2523190-2019-00151
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K080257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV6385R
• Device Lot Number: 200902MF1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1