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

Model Number	US354
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap that a monopolar cable (part # us354) was used during a hernia repair procedure performed on (b)(6) 2020.According to the complainant, the cable, where the plug of the bovie connected to the cord, completely burned up and separated.The device was returned to the manufacturer for evaluation.No patient complications or surgical delay occurred as a result of this event.Additional information has been requested, but has not yet been made available.
Additional Manufacturer Narrative
Manufacturing site evaluation: the complaint device was returned to the manufacturer for evaluation.A visual examination revealed that the device was received with the bovie connector disconnected from the rest of the device.The bovie connector strain relief and insulation was removed adjacent to the thumb/finger grip section of the connector to observe the condition of the wire strands of either side of the break point.The strands, proximal to the connector, had a compressed appearance, rather than looking stretched and necked.Significant corrosion was observed on all the wire strands at the cable break point.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.The investigation into the reported event was able to confirm a failure of the device.However, based on the varied condition of the device, it is highly suggestive of the device having been used well past its designed service life, and possibly being subjected to less than careful handling and maintenance according to published end user guidance.There was no indication that the device issue occurred as a result of a defect in design, materials, or workmanship.

• 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: 11059336
• Report Number: 2916714-2020-00719
• Device Sequence Number: 2876006
• Product Code: GEI
• UDI-Device Identifier: 04046964582820
• UDI-Public: 4046964582820
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/25/2022

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: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/25/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown