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

Model Number	27026CA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not returned.
Event or Problem Description
Allegedly, during a cystoscopy procedure the surgeon noticed the tip of the sheath was gone.He located the piece in the patient's bladder but was unable to retrieve it.Patient was admitted to the hospital and then returned to surgery the next day for an open procedure wherein the tip was retrieved.The hospital did not report injury to the patient.
Additional Manufacturer Narrative
The device was not returned to us, but we did receive pictures.In the first picture, the labeling was worn and blurry and showed a date code of uw.The second picture shows that the beak is completely detached from sheath; the whole beak coming out is a failure of adhesion/fixation and we see it often on 3rd party repaired devices.The hospital confirmed that they use 3rd party repair.The third picture shows the whole instrument and the shaft is bent.Damage possibly due to wear of use and/or 3rd party repair of instrument; we cannot confirm.Karl storz does not approve of any 3rd party repair and does not provide replacement parts.
Event or Problem Description
This is a supplemental.We were unable to get the product back, but we did receive pictures.We are providing an evaluation based on the pictures.

• Brand Name: CYSTOSCOPE-URETHROSCOPE SHEATH
• Common Device Name: CYSTOSCOPE-URETHROSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• MDR Report Key: 6499083
• Report Number: 9610617-2017-00032
• Device Sequence Number: 606248
• Product Code: ODB
• UDI-Device Identifier: 04048551074176
• UDI-Public: 4048551074176
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• 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: 27026CA
• Device Catalogue Number: 27026CA
• Device Lot Number: UW
• Was Device Available for Evaluation?: No
• 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: 04/17/2017
• Supplement Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1