MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK CEV890C DIA 3.5MM 225MM MONOPOLAR; PFM16

Catalog Number CEV890C

Device Problem Arcing (2583)

Patient Problem Peritonitis (2252)

Event Date 11/27/2019

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.

Event Description

A customer reported that on (b)(6) 2019, during the surgery of a female patient, electric arc from the cev890c dia 3.5mm 225mm monopolar occurred near the wall/parietes of the small intestine.Immediately, the hook was removed from the belly of the patient.The surgeon inspected the hook and the coating was damaged.A new hook (removed from packaging) was use as replacement.On (b)(6) 2019, the patient had another surgery.The patient had peritonitis with lots of fluid in the peritoneum and hole in the colon.The surgery (on duty) rescued the injured part and he had to give ¿hail to the skin¿ (intestinal shunt).Type of surgery: total colectomy with rectal anastomosis by laparoscopy.It was reported that the patient is better now.There was an increase of surgery time due to replacement of another hook.Request for additional information has been sent.

Manufacturer Narrative

Additional information received on 03jan2020 stated that there was a surgical delay of several minutes, (time to go to sterile stock to find another hook to continue the surgery).The action that was implemented after the event occurred was the device was changed for another one.The peritonitis is not a postoperative consequence of the electric arc, according to the surgeon (no link).The event has no new consequence for the patient.The device was returned for evaluation.The dhr for lot no: 3181032 reviewed and no anomalies that could be associated with the complaint were observed.The blue coating of the received device is damaged: a large part is missing and there is three marks.There is a black stain in one of these marks: this is the consequence of an electric arc.The black ring under the handle moves and the insulation sheath is shortened near the handle.The electric arc is due to the damages on the coating.These damages are probably due to an improper handling of the device, as an attempt of the disassembly of the non-dismountable device for cleaning, despite of the recommendations of the 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 (b)(6), 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: HOOK CEV890C DIA 3.5MM 225MM 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: 10276875
• MDR Text Key: 201577804
• Report Number: 2523190-2019-00148
• 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
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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: CEV890C
• Device Lot Number: 3181032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Manufacturer Received: 12/05/2019
• 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
• Patient Age: 3 MO