MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CLEVER CUT 3

Model Number CLEVERCUT3 35GW

Device Problem Break (1069)

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

Event Date 09/06/2014

Event Type  Other  

Event Description

While performing a small sphincterotomy of approximately 8mm in the 11:00 position, during the first attempt to do the sphincterotomy, immediately once it started the wire broke.Described by the physician as a wire shorted, burned while inside the patient.Erby cautery (settings: 150 endo and 3 nessy).

• Brand Name: CLEVER CUT 3
• Type of Device: CLEVER CUT 3
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; tokyo 192- 8507
• MDR Report Key: 4109230
• MDR Text Key: 4703178
• Report Number: MW5038255
• Device Sequence Number: 1
• Product Code: FDR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/15/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: CLEVERCUT3 35GW
• Device Catalogue Number: GL751200
• Device Lot Number: 38K
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 78