MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HYDRATOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00583050

Device Problem Defective Device (2588)

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

Event Date 09/11/2017

Event Type  malfunction  

Event Description

After they started to make a sphincterotomy, the cutwire would no longer bow or tighten.The case was completed with another tome of the same part number.Manufacturer response for unit, electrosurgical, endoscopic (with or without accessories), hydratome rx 44 (per site reporter).Replaced the item and asked for the defective item to be returned.

• Brand Name: HYDRATOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 500 commander shea blvd; quincy MA 02171
• MDR Report Key: 7211876
• MDR Text Key: 97974213
• Report Number: 7211876
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729755203
• UDI-Public: (01)08714729755203(17)200426(10)20578029
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2017,09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/26/2020
• Device Model Number: M00583050
• Device Lot Number: 20578029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NOT APPLICABLE.