MAUDE Adverse Event Report: STRYKER ENDOSCOPY 90-S ACCELERATOR 4.0MM X 135MM SUCTION PROBE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0279-351-400

Patient Problem Foreign Body In Patient (2687)

Event Date 08/23/2023

Event Type  Injury  

Event Description

Surgeon was using the serfas probe 90-sx suction probe, shortly after inserting the probe into the patients left knee for the first time, one of the four electrode balls broke off inside the knee cavity.The small piece, approximately 1mm in size, was immediately seen on the arthroscopy camera but was difficult to grasp.A 70 degree scope was opened for better visualization, but the small piece could not be grasped.A mucous trap was placed on the end of the suction probe, in hopes of filtering the small piece and confirming its exit from the knee cavity.Suction was applied and the fragment was likely suctioned out but was too small for the trap and therefore its exit could not be confirmed.The knee cavity was thoroughly examined, fragmented piece not seen.

• Brand Name: 90-S ACCELERATOR 4.0MM X 135MM SUCTION PROBE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court; san jose CA 95138
• MDR Report Key: 17827551
• MDR Text Key: 324498059
• Report Number: MW5146208
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2023
• Device Catalogue Number: 0279-351-400
• Device Lot Number: 23069A32
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White