MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI METAL OUTER SHEATH

Model Number	38700
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufactures internal number is (b)(4).Investigation is on-going.Product will not be returned.Product is in mozambique.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.
Event or Problem Description
It was reported that there was an issue with the product 38700 robi metal outer sheath.According to the information received the doctor stated that at the beginning of the procedure the instruments melted and burned when they were used with the older equipment.There was no patient/usert harm/injury reported.
Additional Manufacturer Narrative
Per the manufactures investigation findings: since the item was not sent in for examination, the extent of the damage cannot be precisely defined.Likewise, it is not known with which other articles the socket was used, whether the correct combination was mounted.Based on these findings, a user error must be assumed.The manufactures internal number is (b)(4).
Additional Manufacturer Narrative
The reported device was returned for evaluation.The evaluation found no problem with the reported device.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ROBI METAL OUTER SHEATH
• Common Device Name: ROBI METAL OUTER SHEATH
• 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, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave.; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17262399
• Report Number: 9610617-2023-00149
• Device Sequence Number: 12487211
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 38700
• Device Catalogue Number: 38700
• Device Lot Number: ZN01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 12/26/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/18/2023; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: 38710MW; 38710MW
• Patient Sex: Female