MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTOSCOPE SHEATH, 22 FR.; CYSTO SHEATH

Model Number 27026B

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

As per manufacturer incident report #(b)(4) received from the factory in germany: according to the received information the distal tip of the cystoscope sheath (27026b) has broken and come away from the sheath.The patient reported discomfort and pain after the procedure, whereupon further investigation was done and the distal tip of the cystoscope sheath was found in the patient's body.After a period of 2 weeks a sconed procedure for removal was performed and no further consequences or impacts were reported.

Manufacturer Narrative

The affected product has been requested for investigation by the manufacturer.When the affected product has been returned to the manufacturer, an investigation of the returned product will be conducted.

Manufacturer Narrative

The concerned cystoscope sheath, 22 fr.(27026b) was returned on 27 july 2022 and investigated by the manufacturer.Upon inspection of the instrument the separation of the distal tip could be confirmed.The root cause for the loosened spot is most likely due to normal wear and tear, caused by a high cycle of reprocessing.

• Brand Name: CYSTOSCOPE SHEATH, 22 FR.
• Type of Device: CYSTO 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 ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15075059
• MDR Text Key: 296307935
• Report Number: 9610617-2022-00121
• Device Sequence Number: 1
• Product Code: ODB
• UDI-Device Identifier: 04048551098127
• UDI-Public: 4048551098127
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27026B
• Device Catalogue Number: 27026B
• Device Lot Number: PS10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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): Required Intervention