MAUDE Adverse Event Report: KARL STORZ SE & CO. KG NEPHROSCOPE ONLY FOR MIP L

Model Number	27840KA
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the objective lens come out from tip during a procedure.No negative impact in state of health reported.On april 15, 2024 we got new information, that during procedure the lens fall out inside patient body and caused a prolongation for more than 60 minutes.It is unclear if the separated part could be retrieved.Therefore, as a precaution, the case is deemed reportable.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The item in question was returned to the manufacturer.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
Result of investigation: the information provided by the customer can be confirmed.Due to the missing or dissolved distal solder seam and the loss of the distal cover glass, the rod lens system has clearly protruded from the system tube.The investigation revealed that the process chemicals used, and their exposure time caused the solder seam to dissolve and the cover glass to fall out.This allowed the rod lens system to escape from the system tube and moisture to penetrate the exposed rod lens system.The defect was caused by incorrect reprocessing or incorrect process chemicals and incorrect exposure time (user error).The damage is not due to a production error.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: NEPHROSCOPE ONLY FOR MIP L
• Common Device Name: NEPHROSCOPE
• 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: 19175977
• Report Number: 9610617-2024-00116
• Device Sequence Number: 6500036
• Product Code: FGA
• UDI-Device Identifier: 04048551366660
• UDI-Public: 4048551366660
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K940594
• 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
• Report Date (Section B): 07/01/2024

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: Health Professional
• Device Model Number: 27840KA
• Device Catalogue Number: 27840KA
• Device Lot Number: 1003RC
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 04/26/2024; Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/17/2024; 07/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown