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

Catalog Number	8400000000
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Codes	Arrhythmia (1721); Chest Pain (1776); Fall (1848); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Pain (1994); Ambulation or Postural Difficulties (2544); Full thickness (Third Degree) Burn (2696); Unspecified Nervous System Problem (4426); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Full udi is not available due to missing serial number.
Event or Problem Description
It was reported that the patient was shocked during a procedure with a rf generator.The patient stated he has experienced tachycardia, chest pain, and fatigue.The patient also stated he has experienced falls, difficulty walking, extreme pain, neurological issues, and a third-degree burn.At this time, it is unknown what caused the shock or burn to the patient.Additional information is being gathered.
Event or Problem Description
He patient was not able to provide any further information regarding the reported event.
Additional Manufacturer Narrative
A medical safety director at stryker was consulted regarding the reported event.In summary, the symptoms reported by the patient would more likely be seen immediately after a high voltage event (>1000 v).It is not possible for our device to achieve a level that high.The reported symptoms would have been noted and treated at the time of admission.A late on-set of symptoms like this has not been observed, based on previous clinical research; therefore, it is unlikely that the stryker device caused or contributed to the reported event.

• Brand Name: MULTIGEN2 RF GENERATOR
• 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22586178
• Report Number: 3015967359-2025-01302
• Device Sequence Number: 9392955
• Product Code: GXD
• UDI-Device Identifier: 07613327173642
• UDI-Public: (01)07613327173642
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 8400000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White