MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VENOM(TM) RF CANNULA, CVD, 100MM, 20G; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number 0406-660-125

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/03/2018

Event Type  malfunction  

Event Description

It was reported that during the procedure the active tip of the cannula broke off in the patient.There were no attempts made to remove the device material left behind.The procedure was completed successfully without a clinically significant delay and there were no additional adverse consequences to the patient.

Event Description

It was reported that during the procedure the active tip of the cannula broke off in the patient.There were no attempts made to remove the device material left behind.The procedure was completed successfully without a clinically significant delay and there were no additional adverse consequences to the patient.

• Brand Name: VENOM(TM) RF CANNULA, CVD, 100MM, 20G
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7455081
• MDR Text Key: 106384606
• Report Number: 0001811755-2018-00626
• Device Sequence Number: 1
• Product Code: GXD
• UDI-Device Identifier: 7613327118414
• UDI-Public: (01)7613327118414
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406-660-125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2018
• 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: Initial
• Patient Sequence Number: 1