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

Catalog Number	0279351653
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: suction probe charred tissue.Probable root cause: inappropriate selection of power by user, wrong default setting, power output variation, console error, use error.
Event or Problem Description
It was reported that the probe charred the tissue.The procedure was completed successfully.

• 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: 8085538
• Report Number: 0002936485-2018-00698
• Device Sequence Number: 11114455
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

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: 18267AE2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1