MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO RF GENERATOR (EUROPE); GENERATOR, LESION, RADIOFREQUENCY

Catalog Number 0406800000E

Device Problem Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2016

Event Type  malfunction  

Event Description

It was reported during a procedure at the user facility the device did not display any impedance resulting in the procedure being cancelled.

Manufacturer Narrative

The reported device was not received for evaluation.The event was not confirmed; however, the account advised they realized they attempted to use the wrong cables with the device which caused the event.The device was not returned for evaluation for this reason.Customer opted to not return for evaluation.

Event Description

It was reported during a procedure at the user facility, the device did not display any impedance resulting in the procedure being cancelled.

• Brand Name: RF GENERATOR (EUROPE)
• 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: 5531256
• MDR Text Key: 41335624
• Report Number: 0001811755-2016-00336
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406800000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• 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