MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION SINGLE USE 3-LUMEN SPHINCTEROTOME

Model Number KD-V411M-0725

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

Olympus medical system corp.(omsc) was informed that during an endoscopic sphincterotomy (est) with sphincterotome, the cutting wire of the subject device broke.The doctor completed the procedure with another device.During the investigation, omsc found the plastic coating on the cutting wire was partially missing.There was no report of pt injury regarding this report.

Manufacturer Narrative

The investigation also confirmed that the cutting wire was broken at the coated portion and the broken section was melted and burned.Approximately coating was missing for 6.5mm from the broken point.There were no other abnormalities related to the breakage in the subject device.Also as the result of checking the mfg record of the same lot, nothing abnormal detected.As the result of investigation, omsc assumes that the damage of the coating occurred due to contacting with the metal part of the forceps elevator of the endoscope.The exposed cutting wire from the damaged coating contacted or came close to the metal part of the forceps elevator while activating the output, which caused spark and a part of the cutting wire became extremely hot, resulting in breakage.The coating broke off and came off from the cutting wire because of the user handling after the cutting wire was broken.The device instruction manual has warned users that "when inserting the instrument into the endoscope, be sure that the cutting wire is parallel to the tube.Otherwise, the metal part of the forceps elevator may contact the cutting wire and peel off the coating material".This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME
• Type of Device: SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4209419
• MDR Text Key: 18643288
• Report Number: 8010047-2014-00555
• Device Sequence Number: 1
• Product Code: FDR
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KD-V411M-0725
• Device Lot Number: K4612
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1