MAUDE Adverse Event Report: AESCULAP AG MONOPOLAR HOOK ELECTRODE 3.5MM 290MM; DISPOSABLE INSTRUMENTS

Model Number	GK398R
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to aesculap ag that a monopolar hook electrode 3.5mm 290mm (part # gk398r) was used during a procedure performed on (b)(6) 2021.According to the complainant, the device insulation cracked near the distal tip.Reportedly, the instrument cauterized an unintended area of the liver.The complaint device was returned to the manufacturer for evaluation.No patient harm was reported.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Visual investigation: we made a visual inspection of the product.Here we found that the shaft was bent.Furthermore, we detected the insulation was damaged.The cause of the cracked / broken down insulation around the distal tip of the instrument is a usage / handling / reprocessing related deviation.There is actually no hint regarding a manufacturing issue.Batch history review due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: failure mode was discussed in psc and evaluation error pattern for monopolar hook electrode 3.5mm 290mm with the result that this case was reportable.A product safety case (psc) was initiated.

• Brand Name: MONOPOLAR HOOK ELECTRODE 3.5MM 290MM
• Common Device Name: DISPOSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12775509
• Report Number: 9610612-2021-00718
• Device Sequence Number: 6119554
• Product Code: GCJ
• UDI-Device Identifier: 04046963520717
• UDI-Public: 4046963520717
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K982623
• 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): 07/29/2022

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: GK398R
• Device Catalogue Number: GK398R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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
• Patient Sex: Unknown