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

Model Number	GK398R
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.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.Although requested, additional information has not been made available.The malfunction is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Investigation results: 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.
Event or Problem Description
No changes required.

• 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
• MDR Report Key: 12775483
• Report Number: 2916714-2021-00220
• Device Sequence Number: 6025229
• Product Code: GCJ
• UDI-Device Identifier: 04046963520717
• UDI-Public: 4046963520717
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022
• Report Date (Section F): 11/08/2021

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: 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2021
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 08/11/2022
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/08/2021