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

Model Number M00545180

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2022

Event Type  malfunction  

Event Description

Bowed up on the cutting wire to do a sphincterotomy and when md stepped on the pedal to cut, the cutting wire broke.

• Brand Name: AUTOTOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15369603
• MDR Text Key: 299381085
• Report Number: 15369603
• Device Sequence Number: 1
• Product Code: KNS
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00545180
• Device Catalogue Number: M00545180
• Device Lot Number: 29242323
• 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: 08/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male