MAUDE Adverse Event Report: AESCULAP INC. MONOPOLAR CABLE W/LG PIN, 10 FEET; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	US354
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information or investigation results become available, a supplemental report will be provided.
Event or Problem Description
It was reported that the monopolar cable w/lg pin, 10 feet malfunctioned during a procedure.The product started "sparking" and the issue was noticed quickly.A back-up device was readily available to successfully complete the procedure.There was a short surgical delay (a couple of minutes).An additional medical intervention was not required and there was no harm to the patient or staff.In the pre-check preoperatively, the nurse had noted that the cord was without nicks or frayed wires.
Additional Manufacturer Narrative
Manufacturing site evaluation: the complaint device was returned to the manufacturer for evaluation.A visual examination revealed that the proximal connector of the cord was completely severed with burn marks along the insulation.An extensive amount of oxidation was found all along the wiring of the cord.The level of oxidation increased the resistance of the wire to a degree that caused a joule heating event that likely resulted in the sparking and severing of the cord.The device history records (dhr) were not able to be reviewed as the lot number was not made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.There was no evidence to suggest any defect in the design, materials, or workmanship of the device.Although no lot number was available, based on the level of oxidation, the cord was likely used beyond its life expectancy.

• Brand Name: MONOPOLAR CABLE W/LG PIN, 10 FEET
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 11456771
• Report Number: 2916714-2021-00027
• Device Sequence Number: 3105917
• Product Code: GEI
• UDI-Device Identifier: 04046964582820
• UDI-Public: 4046964582820
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K913514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 04/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 02/16/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELECTROCAUTERY UNIT.
• Patient Sex: Unknown