MAUDE Adverse Event Report: AESCULAP AG SHAFT ONLY F/MODULAR MONOPOL.ELECTR; HANDHELD PRODUCTS & LIGATION

Model Number	GK370P
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Scratched Material (3020)
Health Effect - Clinical Code	Bowel Burn (1756)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an inner tube w/handle for gk372r (part # gk373r) was used during a laparoscopic procedure on an unspecified date.According to the complainant the l hook used during the surgery burned the duodenum in two (2) places.Additional information received on august 30, 2024, reported that the patient required sutures.The adverse event is filed under aic reference (b)(4).2916714-2024-00144 (aic reference no.(b)(4).
Additional Manufacturer Narrative
Additional information: d9 device returned to manufacturer.The sample provided was returned to the manufacturing site for technical evaluation.Results of the investigation determined that the gk370p shows a crack and melted/charred spots on its outer surface.Apart from this, the instrument is in a proper condition.During a microscopical investigation we found a crack that branched in different directions, the center of the charred spots is in the center of the crack.In contrast to the bipolar rf surgical technique, in which the working current flows from one electrode of the instrument to the other - i.E.The patient's body remains free of current except for the area between the electrodes - in the monopolar surgical technique the working current flows from the electrode across the area to be treated surgical field through the entire body of the patient against the operating table or on the patient's body attached, so called "neutral electrodes".Whereas with bipolar instruments, insulation faults on the shaft of the instrument generally do not lead to any major problems, as there is no large electrical potential difference against the patient's body, insulation faults in monopolar instruments have the effect of creating a second, undesired current path.If the leakage current at this point is large enough, this leads to burns on or in the patient's body.The complained instrument shows cracks in the outer tube - the insulation against the inner shaft carrying the rf voltage - through which the rf voltage "leaks" in several places.The resulting current caused small electric arcs, which led to burn and scorch marks on the instrument and burns on/in the patient.

• Brand Name: SHAFT ONLY F/MODULAR MONOPOL.ELECTR
• Common Device Name: HANDHELD PRODUCTS & LIGATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 20327796
• Report Number: 2916714-2024-00145
• Device Sequence Number: 18108546
• Product Code: GEI
• UDI-Device Identifier: 04038653172450
• UDI-Public: 04038653172450
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024
• Report Date (Section F): 09/27/2024

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: GK370P
• Device Catalogue Number: GK370P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/30/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/03/2024
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/27/2024