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 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by the manufacturer, karl storz in (b)(4).As per the evaluation: the shaft was found to be bent, with a deflection of approximately 4 mm.This indicates high force application, which results in high leverage forces on the connection between the shaft and the tip.The broke off tip shows deformation, which indicates high force application.No indications for a material or manufacturing related issue were found during the investigation.The root cause most probably is too high force application, following high leverage forces on the connection of the tip of the shaft.A warning to not overload the instrument by exerting too much force is included in the ifu.The device was manufactured in may 2006.

Event Description

As per a vigilance report filed with the (b)(6) in (b)(6), by our parent company in (b)(4): beveled end of cystoscope sheath became detached and remained in patient for 18 months.Patient had urological issues, pain, poor flow when passing urine.Patient returned to theatre with a what was thought to be a stone; when trying to break the stone apart, it was discovered to be the beveled end of the cystoscope sheath.

• 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: 9469722
• MDR Text Key: 194176307
• Report Number: 9610617-2019-00116
• 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: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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: ED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2006
• 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