MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VENOM(TM) RF CANNULA, CVD, 100MM, 18G; PROBE, RADIOFREQUENCY LESION

Catalog Number 0406-860-125

Device Problem Biocompatibility (2886)

Patient Problem Local Reaction (2035)

Event Date 04/29/2021

Event Type  malfunction  

Event Description

It was reported that a couple of days following an rf ablation procedure the patient presented with pain at the site of ablation during a telemedicine appointment.Upon referral to a dermatologist an allergic reaction was diagnosed and silver sulfadiazine cream was prescribed.The site has continued to heal and no further adverse consequences have been reported.

Event Description

It was reported that a couple of days following an rf ablation procedure the patient presented with pain at the site of ablation during a telemedicine appointment.Upon referral to a dermatologist an allergic reaction was diagnosed and silver sulfadiazine cream was prescribed.The site has continued to heal and no further adverse consequences have been reported.

Manufacturer Narrative

H3 other text : device not returned.

• Brand Name: VENOM(TM) RF CANNULA, CVD, 100MM, 18G
• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 11886308
• MDR Text Key: 252711330
• Report Number: 3015967359-2021-00963
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 37613327118606
• UDI-Public: 37613327118606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406-860-125
• Device Lot Number: 6000088491
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1