MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER TUBE WITH CERAMIC BEAK

Model Number 27050XB

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

The broken instrument was not returned for evaluation.During our investigation of the previous complaint mentioned in the event description of this report, we learned that inner tube was 3rd party repaired, as the ceramic beak was not of our manufacture.The most likely cause of the ceramic beak breaking is mechanical force.

Event Description

During our investigation of a complaint regarding an inner tube ceramic beak that broke off into a patient, we were informed by the facility that, allegedly, they had previous case during which a piece of the inner tube's ceramic beak broke off into the patient; the procedure was a right ureteroscopy, right retrograde pyelogram, laser lithotripsy, attempted ureteral stent insertion procedure.The hospital stated that the scrub nurse noticed the beak was missing a piece; the patient was x-rayed immediately and the broken piece was seen in the bladder and the surgeon retrieved it during the same procedure.They reported there was no harm to patient.

• Brand Name: INNER TUBE WITH CERAMIC BEAK
• Type of Device: INNER TUBE WITH CERAMIC BEAK
• 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: 8791511
• MDR Text Key: 151119140
• Report Number: 9610617-2019-00061
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551078167
• UDI-Public: 4048551078167
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050XB
• Device Catalogue Number: 27050XB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 58 YR
• Patient Weight: 117