MAUDE Adverse Event Report: CAREFUSION, INC UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 88-9199

Device Problems Flare or Flash (2942); Naturally Worn (2988)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Pr # (b)(4) - 04feb2021 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

Hold for marlo 2.17 per email: event description per attached email states: i received a call from a customer who stated the cord burned completely through at the blue end that connects to instrument during surgery.Doctor is concerned this could be a bad lot.Material no.: 88-9199; lot no.: 110882.Doe: (b)(6) 2021.No injuries.15feb2021 additional information: cut/coag was set at 30/30.Surgeon was using cord and disposable laparoscopic hook auto suture scissors laparoscopic cholecystectomy.No further information available.

Event Description

Event description per attached email states: i received a call from a customer who stated the cord burned completely through at the blue end that connects to instrument during surgery.Doctor is concerned this could be a bad lot.Material no.: 88-9199; lot no.: 110882.Doe: (b)(6) 2021.No injuries.15feb2021 additional information: cut/coag was set at 30/30.Surgeon was using cord and disposable laparoscopic hook auto suture scissors laparoscopic cholecystectomy.No further information available.

Manufacturer Narrative

Follow up (b)(4).The complaint product was returned, and an evaluation was performed.The product at the time of manufacturing would have conformed to all specifications for the production.The root cause for the reported issue is most likely due to wear during maintenance/processing, excessive use, and sterilization, and appears to have reached end of life.The product was returned for evaluation.We were able to confirm that the lot number on the device was 110882.This lot number was sold to carefusion in (b)(6) 2018.Based on this information, the product has been in use for approximately two years and two months.Upon our evaluation of the product, it was noted the device showed significant signs of wear and tear.This wear and tear occurred over the two year and two-month time period it was in use.This product has a recommendation of twenty uses.Extensive bending at the instrument end will cause the wires to wear over time and short out internally.The probable root cause has been determined to be extensive use over two years and two months that caused wear and tear to the internal wiring.There have been no issues identified with the material or manufacturing process.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 11338144
• MDR Text Key: 232201625
• Report Number: 1423507-2021-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10885403154805
• UDI-Public: (01)10885403154805
• Combination Product (y/n): N
• PMA/PMN Number: K971540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88-9199
• Device Catalogue Number: 88-9199
• Device Lot Number: 110882
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other