MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR SINGLE-USE POLYPECTOMY SNARE; SNARE, FLEXIBLE

Model Number M00562450

Device Problem Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

Reported that the captivator small hexagonal would not plug into the erbe cautery for the procedure.The plug-in port was defective by the manufacturer.

• Brand Name: CAPTIVATOR SINGLE-USE POLYPECTOMY SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 16292775
• MDR Text Key: 308736323
• Report Number: 16292775
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729747970
• UDI-Public: 08714729747970
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M00562450
• Device Lot Number: 29728216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White