MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES, 90-S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 0279351100

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 12/15/2022

Event Type  Injury  

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 Description

It was reported that there was a patient burn.

Event Description

It was reported that there was a patient burn.

Manufacturer Narrative

The device manufacturer date is not known.Alleged failure: patient burned on non-operative arm, facility thinks may have come from radiofrequency wand.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Per visual and functional testing no defect and/or manufacturing-related condition was observed that could have contributed to the reported event.The probable root cause/s could be hot saline leaking (due to improper connection between the suction probe and the suction source), the probe suction tubing unintentionally touching the patient's skin and was maintained for a substantial amount of time.Other possibilities were activation of the probe during insertion or removal from the joint space, inadequate suction causing hot saline to leak from the joint space, and fluid irrigation.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: RF 2 PROBES, 90-S
• Type of Device: 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: 16199930
• MDR Text Key: 307669121
• Report Number: 0002936485-2023-00043
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327056952
• UDI-Public: 07613327056952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

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
• Device Operator: Health Professional
• Device Model Number: 0279351100
• Device Catalogue Number: 0279351100
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other