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

Catalog Number 0406900000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2016

Event Type  malfunction  

Event Description

It was reported during a surgical procedure at the user facility the device would not ablate in normal mode resulting in the procedure being cancelled.No further information was provided by the user facility.

Manufacturer Narrative

The reported device was not received by the manufacturer for evaluation.Customer did not return for evaluation.

Event Description

It was reported during a surgical procedure at the user facility the device would not ablate in normal mode resulting in the procedure being cancelled.No further information was provided by the user facility.

• 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: 5517118
• MDR Text Key: 40933455
• Report Number: 0001811755-2016-00319
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406900000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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