MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MULTIGEN RADIOFREQUENCY GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number	0406900000
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device delivered an unintended electrical shock.1 event had patient involvement; patient experienced an unintended electrical shock.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.  supplemental rationale 1 previously reported event is included in this follow-up record.  product return status 1 device was not available for evaluation.H3 other text : device not available for evaluation.
Event or Problem Description
This report summarizes 1 malfunction event in which the device delivered an unintended electrical shock.1 event had patient involvement; patient experienced an unintended electrical shock.

• Brand Name: MULTIGEN RADIOFREQUENCY GENERATOR
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8545830
• Report Number: 0001811755-2019-01333
• Device Sequence Number: 1731295
• Product Code: GXD
• UDI-Device Identifier: 07613154578443
• UDI-Public: 07613154578443
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: No Information
• Device Catalogue Number: 0406900000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2019
• Supplement Date Received by Manufacturer: 01/01/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1