MAUDE Adverse Event Report: Stryker Endoscopy-San Jose 90-S XL; electrosurgical, cutting & coagulation & accessories

Catalog Number	0279351103
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that during the hip joint surgery, the metal tip of the radiofrequency ablation electrode fell into the patient's body.The doctor spent about two hours searching under the microscope during the surgery, but failed.Afterwards, an incision was made to search, but it was still not found.The electrode patch is embedded in the body and cannot be removed.

• Brand Name: 90-S XL
• 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 ; +1(408)754-2000
• MDR Report Key: 25784030
• Report Number: 0002936485-2026-00461
• Device Sequence Number: 18829594
• Product Code: GEI
• UDI-Device Identifier: 07613327056976
• UDI-Public: (01)07613327056976(17)270404(10)25094AE2
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/18/2026

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: 0279351103
• Device Lot Number: 25094AE2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown