MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SERFAS 50-S SWEEP XL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0279351653
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
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 probe arced.Please note that the procedure was completed successfully.
Event or Problem Description
It was reported that the probe arced.Please note that the procedure was completed successfully.
Additional Manufacturer Narrative
This part arced and cracked two scopes without directly touching either scope.Part also clogged periodically.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be the burning tissue blocking the electrode suction pathway.The user with poor or no suction during use, inappropriate selection of power by the user, a wrong default setting, power output variation.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.

• Brand Name: SERFAS 50-S SWEEP XL
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7802088
• Report Number: 0002936485-2018-00584
• Device Sequence Number: 1535503
• Product Code: GEI
• UDI-Device Identifier: 07613327405828
• UDI-Public: 07613327405828
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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: 0279351653
• Device Lot Number: 18157AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1