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

Model Number	0279351650
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the tip broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: the tip electrode was broken off into the patient.The broken off flake/tip was retrieved and discarded.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be excessive force used when inserting removing the probe, a probe inserted into an obstructed passageway, or any forceful impact to the tip of the probe with rigid objects.The probe is used as a tool for a mechanical displacement of tissue or bone, or to pry or scrub.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the tip broke during the procedure.All pieces were retrieved.

• Brand Name: SERFAS 50-S SWEEP +
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11032370
• Report Number: 0002936485-2020-00541
• Device Sequence Number: 13779983
• Product Code: GEI
• UDI-Device Identifier: 07613327405811
• UDI-Public: 07613327405811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/09/2021

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 Model Number: 0279351650
• Device Catalogue Number: 0279351650
• Device Lot Number: NR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1