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

Model Number 27026BA

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation found the instrument with corrosion inside the sheath and creases at the distal end.The distal tip is missing from the sheath.

Event Description

Allegedly per the customer, during the removal of a stent in a urology procedure, the tip of the sheath fell into the patient's bladder, the tip was retrieved by the doctor in one whole piece.The procedure was completed with no other intervention and no harm to the patient.

• Brand Name: CYSTOSCOPE-URETHROSCOPE SHEATH 22FR.
• Type of Device: UROLOGY 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 ; 4242188201
• MDR Report Key: 9145372
• MDR Text Key: 194172338
• Report Number: 9610617-2019-00087
• Device Sequence Number: 1
• Product Code: ODB
• UDI-Device Identifier: 04048551231630
• UDI-Public: 4048551231630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943697
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• 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: ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 68