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

Model Number	88-9199
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pr # (b)(4) 17may2021 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
Complaint for monopolar cautery cord.I do not know the lot number.Was used on patient and patient had extensive bleeding due to cord not conducting with the endoscopic hot snare.Had to use endoscopic clips to help stop bleeding, which is an extra charge to patient.After several clips, the doctor requested to hot snare again.At that point, we noticed there was no coagulation occurring.I suggested using a different cord at which the new cord worked with no trouble.Cord is not available for return for evaluation.The cord was thrown away.Per complaint details received: monopolar cautery cord they ordered stopped working after only a few uses.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 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 11896042
• Report Number: 1423507-2021-00035
• Device Sequence Number: 14360937
• Product Code: GEI
• UDI-Device Identifier: 10885403154805
• UDI-Public: (01)10885403154805
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 05/25/2021
• Report Date (Section F): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/27/2021
• 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: Required Intervention