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

Model Number	27840KA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
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.Internal karl storz reference number: (b)(4).
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 (b)(6) 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.

• 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
• MDR Report Key: 19175981
• Report Number: 2020550-2024-00116
• Device Sequence Number: 6500040
• Product Code: FGA
• UDI-Device Identifier: 04048551366660
• UDI-Public: 4048551366660
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2024
• Report Date (Section F): 04/24/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown