MAUDE Adverse Event Report: AESCULAP INC. AESCULAP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	GK383R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to mw5175620: following the end of the total lap hysterectomy, bilateral salpingectomy, lysis of adhesions, and after the removal of the j hook the lip was noted to be missing.Careful suction and inspection of the abdomen and pelvis was done however the lip was not encountered.Intra operative abdominal and pelvic x rays were done and the images reviewed with radiology real time.The x-rays were noted to be normal showing the uterine manipulator (which was still in place as we had not completed the colpotomy) but no tip of the j hook.The suction was inspected and drained.The ports were changed.The tip was not encountered.Since the x-ray was normal, we completed the colpotomy with a new hook without complication.The uterus and cervix were removed vaginally.The uterus and cervix were also inspected and the tip was not encountered.All instruments were removed and the gas allowed to escape.The skin was closed with 3-0 vicryl in a subcuticular fashion and dermabond.The drapes, gowns, shoe covers were inspected careful.The broken tip of the j hook was encountered under the drape next to the patient.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Additional information/correction: b5 - description updated.D4 - model number updated.Five (5) photographs were provided for technical evaluation.In one (1) of the provided pictures of an handle "gk373r" is shown.The gk373r is a component of the gk372r (gk370p & gk373r = gk372r).The complaint is about a gk372r.In the other picture an electrode body attached to the shaft of an gk372r is shown.The tip of this electrode is missing; the type of this defective electrode is unknown.It is either an gk383r or an gk384r.The problem reported could be confirmed based on the attached image.Based on the investigation findings, the root cause for the fracture could not be determined.The manufacturing site is aware of this issue and has entered this complaint into our trending report.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

• Brand Name: AESCULAP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 23292142
• Report Number: 2916714-2025-00069
• Device Sequence Number: 15959415
• Product Code: GEI
• UDI-Device Identifier: 04038653172498
• UDI-Public: (01)04038653172498
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025
• Report Date (Section F): 08/29/2025

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: GK383R
• Device Catalogue Number: GK383R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/06/2025
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 34 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American
• Date Report Sent to FDA: 08/29/2025