MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES MICRO-CLAW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0279250101
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
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 part of the product remained in the body (ankle joint).The patient mentioned pain during extension.An x-ray suggested the possibility of ceramic remaining in the patient body.The part was removed from patient body completely in an additional procedure.
Additional Manufacturer Narrative
Alleged failure: it is possible that part of the product remained in the body (ankle joint).The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Based on the event description and similar occurrences, the probable root causes could be excessive force used when inserting or removing the probe, insertion of the probe into an obstructed passageway, or any forceful impact to the tip of the probe with rigid objects.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that part of the product remained in the body (ankle joint).The patient mentioned pain during extension.An x-ray suggested the possibility of ceramic remaining in the patient body.The part was removed from patient body completely in an additional procedure.

• Brand Name: RF 2 PROBES MICRO-CLAW
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20871205
• Report Number: 0002936485-2024-00926
• Device Sequence Number: 12961971
• Product Code: GEI
• UDI-Device Identifier: 07613327056877
• UDI-Public: 07613327056877
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160050
• 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): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0279250101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown