MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY RESECTOSCOPE SHEATH WITH BEAK

Model Number	26040XA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation confirmed that the ceramic beak shows char and a small piece is broken off the ceramic tip.The instrument has a date code of hc ((b)(6) 2007) and it has been in use for approximately 9+ years.Also, the beak is white in color; the date code on this one is hc ((b)(6) 2007); we changed from white beaks to gray on ad ((b)(6) 2006); so it does appear that this has been 3rd partied.So a combination of firing inside sheath, wear of long use, and 3rd party repair are possible causes for breakage.
Event or Problem Description
Allegedly, during a cysto procedure the doctor noted that a small piece of 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.

• Brand Name: RESECTOSCOPE SHEATH WITH BEAK
• Common Device Name: RESECTOSCOPE SHEATH WITH BEAK
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• MDR Report Key: 6472579
• Report Number: 9610617-2017-00027
• Device Sequence Number: 13544243
• Product Code: HIH
• UDI-Device Identifier: 04048551092057
• UDI-Public: 4048551092057
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2017

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: 26040XA
• Device Catalogue Number: 26040XA
• Device Lot Number: HC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1