MAUDE Adverse Event Report: CAREFUSION, INC V HOOK ELECTRODE ANGLED 33CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LA8506
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) - 22apr2021 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 or Problem Description
Per complaint details received: instrument appears to be fraying and started sparking during the procedure.They are not sure if this item is flawed, or if they are using it wrong.It appears the insulation on the lower portion of the instrument has come off which allows the instrument to spark when being used on laparoscopic cases.There was not any damage or patient or user injury.No further information available.
Event or Problem Description
Instrument appears to be fraying and started sparking during the procedure.They are not sure if this item is flawed, or if they are using it wrong.It appears the insulation on the lower portion of the instrument has come off which allows the instrument to spark when being used on laparoscopic cases.There was not any damage or patient or user injury.No further information available.
Additional Manufacturer Narrative
Follow up (b)(4).The complaint product was returned, and an evaluation was performed.The product was manufactured in november of 2020.The root cause of the issue is misuse.The insulation that is missing is at the end effector.The fep is 90% gone from the tip.The peek adaptor also shows deterioration.The most likely cause of the insulation deterioration is user error in selecting and using electrical settings during use.Excessive voltage or crest factors settings during use of electrical charge most likely caused the fep to deteriorate.Ifu states ¿do not exceed maximum output voltage of 2000 volts peak at a crest factor <1.6.¿ ifu states ¿do not exceed maximum output voltage of 2100 volts peak at a crest factor <2.8.¿ ifu states ¿do not exceed maximum output voltage of 3000 volts peak at a crest factor <5.5.¿ validation report 042: endoplus coagulator validation testing included an electrical test which was completed per the protocol and showed the insulation at the tip was able to handle electrical loads within the parameters stated on the ifu without exhibiting ¿visible damage to the insulation.¿ furthermore, the ifu states ¿end of life indicators include: damaged, missing, or modified shaft insulation¿.This device is clearly at end of life and should no longer be used.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.H3 other text : see h10.

• Brand Name: V HOOK ELECTRODE ANGLED 33CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 11815739
• Report Number: 1423507-2021-00034
• Device Sequence Number: 11575465
• Product Code: GEI
• UDI-Device Identifier: 10885403053917
• UDI-Public: (01)10885403053917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021
• Report Date (Section F): 05/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: LA8506
• Device Catalogue Number: LA8506
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other