MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HYSTEROSCOPE SHEATH, 5 MM; Hysteroscope (And Accessories)

Model Number	26153EA
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The customer mentioned noted debris inside the shaft and corrosion.It is beleived that the customer was using the non-recommended cleaning solution.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the surgeon observed debris possibly coming from the sheath.It was an appearance of metallic flakes is was small enough that it could not be seen by the naked eye only through the scope and camera.
Additional Manufacturer Narrative
Additional information is make clear that the previous reportability decision for this event was reversed based on a retrospective review.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HYSTEROSCOPE SHEATH, 5 MM
• Common Device Name: Hysteroscope (And Accessories)
• 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: 17873511
• Report Number: 9610617-2023-00275
• Device Sequence Number: 7381453
• Product Code: HIH
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K223885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2026

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: Other
• Device Model Number: 26153EA
• Device Catalogue Number: 26153EA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 09/04/2026
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/04/2023; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown