MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLERMONT-FERRAND MANIPULATOR SHEATH

Model Number	26168DE
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is in transit to manufacturer.The investigation is pending.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): it was reported that the instrument was released during an operation causing problems for the patient.Further information was requested, but not available.
Additional Manufacturer Narrative
This supplement report is to provide facility name and address.
Additional Manufacturer Narrative
The affected unit was returned on 2021-07-08.According to the investigation results, minor cosmetical defects could be found.No malfunction could be found, as the item worked as per manufacturer's specifications.The most probable root cause is that the customer did not assemble the components as described in the instructions for use (document 96126005d, version 3.0 - 11/2017).The name/address/representive of the hospital was not provided despite several requests.Karl storz did not received a feedback or a reference number.

• Brand Name: CLERMONT-FERRAND MANIPULATOR SHEATH
• Common Device Name: SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 12309002
• Report Number: 9610617-2021-00057
• Device Sequence Number: 3671410
• Product Code: HIH
• UDI-Device Identifier: 04048551096017
• UDI-Public: 4048551096017
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K992027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 26168DE
• Device Catalogue Number: 26168DE
• Device Lot Number: XP03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/01/2021; 07/01/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 11/11/2021; 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2015
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown