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

Catalog Number 0406900000

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2016

Event Type  malfunction  

Event Description

It was reported during a surgical procedure at the user facility the device had high impedance which resulted in the procedure being canceled.It was reported there was no medical intervention or adverse consequences beyond the cancellation of the procedure.

Manufacturer Narrative

Additional information: the reported device was received for evaluation; event was not confirmed during testing.Preventative maintenance was performed on the device and it was returned to the user facility.

Event Description

It was reported during a surgical procedure at the user facility, the device had high impedance which resulted in the procedure being canceled.It was reported there was no medical intervention or adverse consequences beyond the cancellation of the procedure.

• Brand Name: MULTIGEN RADIOFREQUENCY GENERATOR
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5643493
• MDR Text Key: 44816128
• Report Number: 0001811755-2016-00708
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0406900000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1