MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY CYSTOSCOPE-URETHROSCOPE SHEATH

Model Number 27026CB

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  malfunction  

Event Description

Allegedly, during a cystoscopy procedure the doctor noted that a piece of the ceramic beak broke off the instrument and fell into the patient's bladder.The doctor conducted an open procedure for removal of retained foreign object.The procedure was completed with no delay.The hospital reported there was no injury to the patient.

• Brand Name: CYSTOSCOPE-URETHROSCOPE SHEATH
• Type of Device: CYSTOSCOPE-URETHROSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188519
• MDR Report Key: 6524014
• MDR Text Key: 74021347
• Report Number: 9610617-2017-00035
• Device Sequence Number: 1
• Product Code: ODB
• 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: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 27026CB
• Device Catalogue Number: 27026CB
• Device Lot Number: UW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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 Age: 77 YR
• Patient Weight: 90