MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI FORCEPS INSERT

Model Number	38610ON
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported "similar intermittent issues and then the bipolar forceps were unable to stop a bleeding (ooze) on the liver following the removal of the gall bladder" (second case (b)(4).The surgeon tried for a good few minutes but the bleeding would not stop.The surgeon had to use "surgicell" as well as "flowseal" to stop the bleeding on the liver and the patient lost about 50 ml of blood.The case was able to be completed following the application of the haemostasis gel.The procedure was delayed by about 30 minutes.No negative impact in state of health reported.

• Brand Name: ROBI FORCEPS INSERT
• Common Device Name: ROBI FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 22372377
• Report Number: 2020550-2025-01128
• Device Sequence Number: 19930657
• Product Code: GEI
• UDI-Device Identifier: 04048551328651
• UDI-Public: 04048551328651
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 07/01/2025
• Report Date (Section F): 06/16/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 38610ON
• Device Catalogue Number: 38610ON
• Device Lot Number: NT35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/16/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 26176LV BIPOLAR HIGH FREQUENCY CORD 300, LOT: NU01.; 38151 ROBI PLASTIC HANDLE, LOT UV05.; 38600 ROBI METAL OUTER SHEATH, LOT UL08.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown