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

Model Number	38600
Medical Device Problem Codes	Smoking (1585); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an issue with one of their bipolar burners prior to procedure.It functioned correctly when tested on a wet wipe and was placed in a bag ready for use.However, the operating room nurse noticed a burnt smell and removed the burner from the bag.Upon retesting, smoke emerged from the end near the jaws, and the burner subsequently failed to operate.No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
The device in question was returned to manufacturer on april 30,2025.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.Additional information reflect in section d10.Concomitant products article: 38151 lot: un05.Article: 26176lv lot: zm01.Article: 38610md lot: pm01 product was returned on april 30,2025.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: during the manufacturer's technical inspection, the error description provided by the customer could be confirmed.The robi forceps insert is melted at the distal end.The heat caused the teflon sleeve to deform.According to the customer's photo, the correct programs were set.However, this is not an hf device from ks but from olympus.Therefore, the exact parameters of the individual programs are unknown.This can cause damage to the mouthpiece.The ifu recommends using a device from ks.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; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21931272
• Report Number: 9610617-2025-00727
• Device Sequence Number: 8650765
• Product Code: GEI
• UDI-Device Identifier: 04048551328606
• UDI-Public: 04048551328606
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2026

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: 38600
• Device Catalogue Number: 38600
• Device Lot Number: YO36
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 01/21/2026
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/14/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ARTICLE: 26176LVLOT: ZM01; ARTICLE: 38151, LOT: UN05; ARTICLE: 38610MDLOT: PM01
• Patient Sex: Unknown