MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. BOSTON SCIENTIFIC HYDRATOME; UNIT, ELECTROSURGICAL, ENDOSCOPIC ((WITH OR WITHOUT ACCESSORIES)

Catalog Number M00583040

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 12/12/2018

Event Type  malfunction  

Event Description

Wire sticking and end of the hydratome hard to feed through.

• Brand Name: BOSTON SCIENTIFIC HYDRATOME
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC ((WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 8208352
• MDR Text Key: 132046277
• Report Number: MW5082710
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2021
• Device Catalogue Number: M00583040
• Device Lot Number: 22698922
• Is the Reporter a Health Professional?: No
• 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 Age: 77 YR
• Patient Weight: 107