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

Model Number	38610MD
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was only reported that the instrument is "broken".The internal assessment revealed that the jaw part is broken.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: during a thorough inspection of the claimed item 38610md, lot sl10, a structural defect was found at the distal end of the instrument.The fork that holds the mouthpiece is broken.In addition, small burrs and indentations are clearly visible on the surface of the fork.The break is located at the rear of the fork, where the bar begins.Furthermore, the investigation shows a clear deformation of the entire item, which indicates the effect of an external force.The combination of indentations in the material, visible surface damage, and the bending of the item strongly suggests that the defect was caused by mechanical overload.From a technical point of view, it can be assumed that the item was subjected to excessive force.This force initially led to plastic deformation (bending) of the instrument and subsequently to overstressing of the fork structure, which ultimately resulted in breakage.The instructions for use (ifu) expressly state that the product must be checked for damage before each use.It also warns against the use of excessive force.The damage pattern indicates that these instructions were not followed.From a technical point of view, it is therefore highly likely that user error was the cause.Improper handling under excessive mechanical force led to the damage observed.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ROBI KELLY FORCEPS INSERT
• Common Device Name: ROBI KELLY FORCEPS INSERT
• 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: 21901878
• Report Number: 9610617-2025-00679
• Device Sequence Number: 4184091
• Product Code: GEI
• UDI-Device Identifier: 04048551328682
• UDI-Public: 04048551328682
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: 38610MD
• Device Catalogue Number: 38610MD
• Device Lot Number: SL10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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
• Patient Sex: Unknown