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

Model Number	88-9199
Medical Device Problem Code	Optical Discoloration (2999)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).28jun2023 writer sent the customer an email acknowledging receipt of the complaint 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
Verbatim: customer reported the cord started to change to a glowing orange color.The end that connects into the instrument that leads to the flexible portion of the hub also near gray cord where cord stops at blueish connecter started to glow orange.The customer reports that they left cord in biohazard bag.Wed 06/28/2023 ¿ what is the material number? 88-9199 ¿ what is the lot number? 100435 ¿ was the product received in this condition? no ¿ please confirm whether or not there was any patient impact.No harm or injury to patient ¿ do you have photos showing the reported issue? yes ¿ attached to the email.¿ is the product available to send back to us for an evaluation? yes.¿ please provide date of incident.(b)(6) 2023.07jul2023 additional information: yes the cord changed to a glowing orange color because it got too hot.The cord started to glow orange in color, but once the cord separated, it went back to the original grey color.No further information is not available.
Event or Problem Description
Verbatim: customer reported the cord started to change to a glowing orange color.The end that connects into the instrument that leads to the flexible portion of the hub also near gray cord where cord stops at blueish connecter started to glow orange.The customer reports that they left cord in biohazard bag.(b)(6) 2023 ¿ what is the material number? 88-9199 ¿ what is the lot number? 100435 ¿ was the product received in this condition? no ¿ please confirm whether or not there was any patient impact.No harm or injury to patient ¿ do you have photos showing the reported issue? yes ¿ attached to the email ¿ is the product available to send back to us for an evaluation? yes ¿ please provide date of incident.(b)(6) 2023.Additional information: yes the cord changed to a glowing orange color because it got too hot.The cord started to glow orange in color, but once the cord separated, it went back to the original grey color.No further information is not available.
Additional Manufacturer Narrative
(b)(4).Follow up the complaint product was returned, and an evaluation was performed.The returned device was reviewed and was confirmed to have signs of significant wear and tear.The lot number was confirmed to be 100435 which was sold to carefusion/bd in 2017.This device is only validated for 20 sterilizations/uses.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.There have been no issues identified with the material or manufacturing process.

• Brand Name: UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17320284
• Report Number: 1423507-2023-00094
• Device Sequence Number: 12384232
• Product Code: GEI
• UDI-Device Identifier: 10885403154805
• UDI-Public: (01)10885403154805
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K971540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: 88-9199
• Device Catalogue Number: 88-9199
• Device Lot Number: 100435
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown