MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GENESYS HTA PROCERVA; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number 58023

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 10/07/2014

Event Type  No Answer Provided  

Event Description

Valve piece of disposable hta handpiece came off in patient.Piece was retrieved without incident or harm to patient.

• Brand Name: GENESYS HTA PROCERVA
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 4180214
• MDR Text Key: 14874061
• Report Number: 4180214
• Device Sequence Number: 1
• Product Code: MNB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Physician
• Device Model Number: 58023
• Device Catalogue Number: 58023
• Device Lot Number: 17229339
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR