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

Catalog Number	0279250201
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
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 a laparoscopic surgery, the product broke inside the patient's body and remained there.After explaining the situation to the family, an open surgery was performed.All broken pieces were removed from the patient body.
Additional Manufacturer Narrative
Alleged failure: the product broke inside the patient's body the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause of the issue could be excessive force applied by the user, combined with poor or inadequate suction during use.The unit may have come into contact with another hard object or device during surgery, or while inserting or removing the probe in an obstructed passageway, which could lead to insulation damage.The unit was returned without the original packaging.Therefore, the lot number (24023ae2 ) on the complaint record cannot be confirmed.However, the product description and the failure mode (or issue or problem, etc.) reported is consistent with the device returned for this event.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that during a laparoscopic surgery, the product broke inside the patient's body and remained there.After explaining the situation to the family, an open surgery was performed.All broken pieces were removed from the patient body.

• Brand Name: RF 2 PROBE MICRO-BRUSH
• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22161313
• Report Number: 0002936485-2025-00521
• Device Sequence Number: 7422050
• Product Code: GEI
• UDI-Device Identifier: 07613327056860
• UDI-Public: 07613327056860
• 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): 08/21/2025

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: 0279250201
• Device Lot Number: 24023AE2
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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: Female