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

Model Number 27026BA

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by the manufacturer, karl storz in (b)(4).As per the evaluation: upon evaluation the tip was found to be loosened.Adhesive residuals were found on the insert and inside the shaft.The shaft was found to be bent.The deflection of the shaft conducts approx.5 mm.Bending of the shaft can cause leverage forces on the insert and loosen the connection.No indications for a material or manufacturing related issue were found during the investigation.The root cause most likely is overloading of the instrument and therefore user related.The device was manufactured in march 2012.Since jan.1, 2009, (b)(4) pieces of this artical were sold world wide, thereof (b)(4) in (b)(4).

Event Description

As per a vigilance report filed with the italian competent authority by our parent company in (b)(4): during a ureteral stent procedure, the distal tip of the cystoscope sheath came off into the patient's bladder.The tip was removed from the patient using forceps under direct vision, and there was no apparent harm to the patient.A replacement cystoscope was used to finish the procedure.

• Brand Name: CYSTO URETHROSCOPE SHEATH, 22FR
• Type of Device: CYSTOSCOPE 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: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 9427859
• MDR Text Key: 194175910
• Report Number: 9610617-2019-00113
• Device Sequence Number: 1
• Product Code: ODB
• UDI-Device Identifier: 04048551231630
• UDI-Public: 4048551231630
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27026BA
• Device Catalogue Number: 27026BA
• Device Lot Number: PX11
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2012
• 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
• Patient Age: 57 YR