MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY INNER TUBE WITH CERAMIC BEAK

Model Number	27040XB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital did not return instrument.
Event or Problem Description
Allegedly, during a procedure the doctor noted that a piece of the ceramic beak broke off the distal end of the instrument and fell into the patient.The doctor immediately removed the broken piece and the procedure was completed with no delay.The hospital reported that there was no injury to the patient.
Additional Manufacturer Narrative
The device was returned for evaluation.We found that the ceramic beak is broken leaving a remnant piece attached and there are dents on the shaft.We believe the cause of breakage is due to stress overload or impact damage; item may have been damaged before the procedure by coming into contact with a hard surface or being dropped; we cannot confirm this.
Event or Problem Description
This is a supplemental report.We are providing evaluation of device and updating other fields as a result.We are correcting date code.

• Brand Name: INNER TUBE WITH CERAMIC BEAK
• Common Device Name: INNER TUBE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• MDR Report Key: 6494977
• Report Number: 9610617-2017-00030
• Device Sequence Number: 19064026
• Product Code: GCJ
• UDI-Device Identifier: 04048551076569
• UDI-Public: 4048551076569
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2017

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: Physician
• Device Model Number: 27040XB
• Device Catalogue Number: 27040XB
• Device Lot Number: GH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1