MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VENOM150MM MULTIGEN2 ELECTRODE; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number	8400-825-015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the probe sheared after sheath was removed.It should be noted that the case was successfully completed with no impact to the patient, no medical intervention, no delays, or any adverse consequences as well.
Event or Problem Description
It was reported that the probe sheared after sheath was removed.It should be noted that the case was successfully completed with no impact to the patient, no medical intervention, no delays, or any adverse consequences as well.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.

• Brand Name: VENOM150MM MULTIGEN2 ELECTRODE
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19528274
• Report Number: 3015967359-2024-01153
• Device Sequence Number: 7501118
• Product Code: GXD
• UDI-Device Identifier: 07613327173697
• UDI-Public: 07613327173697
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K170242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: 8400-825-015
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown