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

Model Number 27026BA

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.

Event Description

Allegedly, during a cystoscopy procedure, the distal tip of the sheath came off into the patient.The piece was retrieved.There was no harm to patient.

• Brand Name: CYSTOSCOPE-URETHROSCOPE SHEATH
• Type of Device: CYSTOSCOPY 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: 8295085
• MDR Text Key: 134871177
• Report Number: 9610617-2019-00017
• 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: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• 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: CE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2005
• 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 Weight: 85