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

Model Number 26168DE

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device is in transit to manufacturer.The investigation is pending.

Event 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.

Manufacturer Narrative

This supplement report is to provide facility name and address.

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
• Type of Device: 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
• MDR Text Key: 266071840
• Report Number: 9610617-2021-00057
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551096017
• UDI-Public: 4048551096017
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K992027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 07/01/2021; 07/01/2021
• Supplement Dates FDA Received: 11/11/2021; 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other