MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SL

Model Number	27050XA
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that part of the brown plastic broke and fell into the patient.This was removed successfully.The procedure was completed successfully with a delay of less than 15 minutes.No additional intervention was required and no negative impact in state of health reported.
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.This event is filed under internal complaint id_(b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 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
Additional information is provided in section d4.Result of investigation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer, " part of the brown plastic broke and fell into the patient.This was removed successfully.", could be confirmed.The investigation revealed mechanical breakage points at the proximal end of the shaft.In addition, a piece of plastic has broken off at the rear of the item.It should be noted additionally that the item was manufactured in july 2010 and that age-related material fatigue may therefore also have played a role.The damage to the shaft and the breakage of plastic parts at the rear of the product were caused by mechanical overload and improper handling.According to the manufacturer's instructions (see dcd218_en_v1.1_ifu_ce-mdr.Pdf, chapters 3.2 and 3.4), the products must not be subjected to excessive mechanical force, and bent parts must not be bent back into shape.Damage such as breakage or chipping is usually caused by improper handling, for example, by applying excessive force during assembly, use, or transport.The responsibility for such damage lies with the user or the reprocessing personnel if the handling does not comply with the specifications.Only through proper use and regular inspection for mechanical defects can the functionality and safety of the product be guaranteed.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH FOR 27050 SL
• Common Device Name: INNER SHEATH FOR 27050 SL
• 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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21720045
• Report Number: 9610617-2025-00517
• Device Sequence Number: 9414365
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 04048551078136
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2025

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: 27050XA
• Device Catalogue Number: 27050XA
• Device Lot Number: UZ05
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 04/02/2025; 10/30/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/17/2025; 04/23/2025; 10/31/2025
• 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