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
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional Manufacturer Narrative
H3 other text : device not returned.

• Brand Name: VENOM(TM) RF CANNULA, CVD, 100MM, 18G
• Common Device Name: 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
• Report Number: 3015967359-2021-00963
• Device Sequence Number: 11683669
• Product Code: GXI
• UDI-Device Identifier: 37613327118606
• UDI-Public: 37613327118606
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K123178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown