MAUDE Adverse Event Report: AESCULAP INC MONOPOLAR CABLE W/LG PIN, 10 FEET; LAPAROSCOPIC SURGERY

Model Number	US354
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information or investigation results become available, a supplemental mdr will be provided.
Event or Problem Description
It was reported that the monopolar cable w/lg pin, 10 feet malfunctioned during cauterization in a procedure.It was noted that the device had been set to 40, a setting typically used by the surgeon without issue.The cord then "burned off "(popped off) and fell to the ground.The cord landed on the ground away from the surgical field.A back-up device was readily available and was used to successfully complete the procedure.There was no additional medical intervention, no harm to the patient and no surgical delay due to the reported event.
Additional Manufacturer Narrative
E- reporter updated.Mdr format corrected (manufacturer report and not an importer report).If additional information or investigation results become available, a supplemental report will be provided.
Event or Problem Description
Additional information was received via mw5097096: during the procedure, there was a break in the monopolar bovie cord.This was approximately 2 inches from the end that connects the cord to the hook cautery.The cord was hot to the touch and glowed orange.There was no patient or employee injury.("serious injury" had been checked off on the form, but an injury nor intervention were noted).
Additional Manufacturer Narrative
The device was returned for evaluation; a lot number was not provided nor visible.Visual inspection was performed.The instrument connector had completely detached from the remainder of the cord.Portions of the cord jacket were stripped and the entire wire within the cord was found to be oxidized (aged and brittle).The level of oxidation increased the resistance of the wire to a degree that caused a joule heating event that resulted in the insulation melting.The lot number of the cord was not provided.However, considering the condition in which it arrived, the cord was likely being used long past its recommended life cycle.There is no evidence to suggest any defect in design, material or workmanship.The cord was used beyond its life expectancy which caused it to fail.

• Brand Name: MONOPOLAR CABLE W/LG PIN, 10 FEET
• Common Device Name: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 10742119
• Report Number: 2916714-2020-00596
• Device Sequence Number: 3450886
• Product Code: HIM
• UDI-Device Identifier: 04046964582820
• UDI-Public: 4046964582820
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2021
• Report Date (Section F): 10/27/2020

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: US354
• Device Catalogue Number: US354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/21/2020; 12/11/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/13/2020; 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELECTROCAUTERY UNIT
• Date Report Sent to FDA: 10/27/2020