MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH, 26 FR.

Model Number	27050SL
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the uterine septal resection maneuver an instrument fragment detached and was recovered inside the uterine cavity.Upon extraction of the instrument, it was realized that the proximal part had desoldere.No negative impact on the state of health of the patient reported.
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id: (b)(4).The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.
Additional Manufacturer Narrative
According to the customer's description, an unspecified part of the resectoscope sheath came loose during the procedure and fell into the patient's uterus.The part could be tracked down again in the uterus during the operation and removed.After removal of the separated part of the sheath, it is described as a desoldered part'.One possible cause of this can be improper reprocessing.The instructions for use indicate the correct handling and the reprocessing methods and media to be used.Since the resectoscope sheath was not returned to karl storz tuttlingen, it is not possible to determine how often it was used and whether it is worn out.Therefore, a more detailed investigation cannot be carried out.Based on the facts given, we assume that it was a case of incorrect use.If the item is nevertheless returned to us and it is possible to examine the item that is the subject of the complaint, the report will be reopened, and the examination results entered.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The product was returned to the manufacturer on january 8, 2025, for investigation.An examination of the returned article 27050xa confirmed the customer's description of the defect.The proximal shaft had detached from the holder, resulting in a break.Additionally, fragments had separated from the diagonal struts.Following consultation with the responsible designer, it was determined that this type of damage cannot occur during normal use, as the inner shaft is permanently installed in the set.Therefore, it is likely that the item sustained mechanical impact during use.Furthermore, since the item was manufactured in 2019 and has undergone multiple reprocessing cycles, material fatigue may have contributed to its failure.The article 27050sl was not submitted for inspection, suggesting it remained undamaged.No serious public health threat has been reported.There have been no reports of death, unexpected serious deterioration in health, or injuries to the patient, user, or any third party.Consequently, the reported issue does not meet the criteria for a serious incident and is therefore not reportable.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: RESECTOSCOPE SHEATH, 26 FR.
• Common Device Name: RESECTOSCOPE SHEATH, 26 FR.
• 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 ; 4242188247
• MDR Report Key: 19840502
• Report Number: 9610617-2024-00229
• Device Sequence Number: 20480236
• Product Code: HIH
• UDI-Device Identifier: 04048551232910
• UDI-Public: 04048551232910
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K221893
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/15/2025

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: 27050SL
• Device Catalogue Number: 27050XA
• Device Lot Number: SQ01
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 01/08/2025; 02/05/2025; 04/14/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 12/19/2024; 01/22/2025; 02/25/2025; 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown