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

Model Number	88-9199
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr # (b)(4).Mw5100219, 29mar2021.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
Event description per attached complaint form states: robotic hysterectomy, monopolar scissors in robot with cord hooked into instrument and generator pulls instrument out of robot.There was a fire on cable - cable split on the blue part of cord still connected to monopolar scissors.No patient harm - extinguished immediately.No further information available.

• 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
• MDR Report Key: 11674908
• Report Number: 1423507-2021-00024
• Device Sequence Number: 11544425
• Product Code: GEI
• UDI-Device Identifier: 10885403154805
• UDI-Public: (01)10885403154805
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2021
• Report Date (Section F): 03/29/2021

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: 88-9199
• Device Catalogue Number: 88-9199
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/15/2021
• 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
• Date Report Sent to FDA: 03/29/2021