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

Catalog Number	0279351650
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during shoulder arthroscopy, the white tip of the rf device chipped off.The broken fragment was subsequently removed.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that during shoulder arthroscopy, the white tip of the rf device chipped off.The broken fragment was subsequently removed.
Additional Manufacturer Narrative
Alleged failure: during shoulder arthroscopy, the white tip of the rf device chipped off.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be unintended use such as; excessive force applied by the user.The unit could have been scrapped with another hard object or device during surgery, or when inserting or removing the probe into an obstructed passageway.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 24252859
• Report Number: 0002936485-2026-00050
• Device Sequence Number: 8326648
• Product Code: GEI
• UDI-Device Identifier: 07613327405811
• UDI-Public: 07613327405811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171391
• 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): 04/01/2026

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: 0279351650
• Device Lot Number: 25190AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown