MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI HANDLE; ROBI PLASTIC HANDLE

Model Number	38151
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an issue with the product 38151 robi plastic handle.According to the information received the doctor was shocked and burned.There was no patient harm/injury reported.
Additional Manufacturer Narrative
The manufactures internal number is (b)(4).Investigation is on-going.Product will not be returned.Ifu im-000004 v11.0(01-2019) bipolar instruments and take-apart bipolar instruments warns to check the bipolar cord for cuts,crimps or burns and to inspect all bipolar instruments prior to and after each procedure for visiable signs of damage.
Additional Manufacturer Narrative
A bipolar cable that was used in the event was left off of section d10 of original filing.
Additional Manufacturer Narrative
Determination: since the item is not sent for examination, it cannot be examined more closely.According to the customer description, the doctor has received a shock / burn.A possible cause may be that the doctor wore no, or defective gloves and the current could thus flow in his body or handle was wet, so that the current was passed here.Ifu im-000004 ifu v11.0 01-2019 warns " use surgical gloves specifically designated by their manufacturer for electro-surgical procedures.The use of other gloves may result in electrosurgical shocks or burns to the surgeon.".

• Brand Name: ROBI HANDLE
• Common Device Name: ROBI PLASTIC HANDLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16859939
• Report Number: 9610617-2023-00093
• Device Sequence Number: 17572319
• Product Code: GEI
• UDI-Device Identifier: 04048551325209
• UDI-Public: 4048551325209
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K962030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2023

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: 38151
• Device Catalogue Number: 38151
• Device Lot Number: UN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 05/08/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/11/2023; 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 26176LE; 38710MW ROBI SCISSORS INSERT38700 ROBI SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 70 KG