MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UROLOGY INNER SHEATH; INNER RESECTOSCOPE SHEATH

Model Number 27050CA

Device Problem Material Separation (1562)

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

The distal tip of sheath broke off inside patient during a cystoscopy.

Manufacturer Narrative

Product has not been returned for evaluation.We have been unable to obtain any information regarding the incident from the facility.

• Brand Name: UROLOGY INNER SHEATH
• Type of Device: INNER RESECTOSCOPE 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 ; 4242188100
• MDR Report Key: 12827705
• MDR Text Key: 280873670
• Report Number: 9610617-2021-00077
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 4048551077412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050CA
• Device Catalogue Number: 27050CA
• Device Lot Number: WS03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male