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

Model Number 38151

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

Event 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.

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.

Manufacturer Narrative

A bipolar cable that was used in the event was left off of section d10 of original filing.

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
• Type of Device: 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
• MDR Text Key: 314459182
• Report Number: 9610617-2023-00093
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551325209
• UDI-Public: 4048551325209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 26176LE; 38710MW ROBI SCISSORS INSERT38700 ROBI SHEATH
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 70 KG