MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44 20 MM CUT WIRE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number M00584040

Device Problem Defective Component (2292)

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

Event Date 09/10/2019

Event Type  malfunction  

Event Description

Bad lot.Fda safety report id # (b)(4).

• Brand Name: DREAMTOME RX 44 20 MM CUT WIRE
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; el coyol, alajuela PR
• MDR Report Key: 9117790
• MDR Text Key: 160208500
• Report Number: MW5090007
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Catalogue Number: M00584040
• Device Lot Number: 23795452
• Was Device Available for Evaluation?: Yes
• 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