MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .014 WIRE; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number	0504880314
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the electrode was fractured during the procedure.The fracture did not take place inside the patient and no pieces fell into the patient.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: the ending of electrode ring was fracture.Probable root cause: manufacturing/assembly error; severe shipping conditions; material/design error; constant irrigation flow is not maintained leading to limited field of view ; large anatomy; damaged or deformed o-ring; use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
Event or Problem Description
It was reported that the electrode was fractured during the procedure.The fracture did not take place inside the patient and no pieces fell into the patient.

• Brand Name: PKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .014 WIRE
• Common Device Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9461875
• Report Number: 0002936485-2019-00556
• Device Sequence Number: 18920937
• Product Code: FAJ
• UDI-Device Identifier: 37613327055437
• UDI-Public: 37613327055437
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K040390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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 Catalogue Number: 0504880314
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1