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

Model Number	27050XB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INNER TUBE WITH CERAMIC BEAK
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8791511
• Report Number: 9610617-2019-00061
• Device Sequence Number: 19327315
• Product Code: FBO
• UDI-Device Identifier: 04048551078167
• UDI-Public: 4048551078167
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 27050XB
• Device Catalogue Number: 27050XB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 117