MAUDE Adverse Event Report: MYOSCIENCE IOVERA SMART TIP (3X6.9MM) ; DEVICE, SURGICAL, CRYOGENIC

Catalog Number STT0513

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/17/2018

Event Type  Injury  

Event Description

Broken needle tip.

• Brand Name: IOVERA SMART TIP (3X6.9MM)
• Type of Device: DEVICE, SURGICAL, CRYOGENIC
• Manufacturer (Section D): MYOSCIENCE; fremont CA 94538
• MDR Report Key: 7797230
• MDR Text Key: 117748433
• Report Number: MW5079227
• Device Sequence Number: 1
• Product Code: GXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: STT0513
• Device Lot Number: 3441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 61