MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V

Model Number KD-V411M-1530

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

The subject product was returned to omsc for investigation.The investigation confirmed that the coating on the cutting wire was torn and the cutting wire was broken.The broken section was melted and burned.Approximately coating was missing for 9.0 mm from the broken point.There were no other abnormalities related to the breakage in the subject device.Also as the checking of the manufacturing record of the same lot, nothing abnormal was detected.The length of the pfa wire, the appearance of the pfa wire, the movement of the cutting wire, the general appearance.This type of damage is most likely related to the operator's technique.As the results of the investigation, omsc assumes that the damage of the coating and cutting wire 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.

Event Description

Olympus medical systems corp (omsc) was informed that during endoscopic sphincterotomy (est), knife wire was broken immediately after energization.Omsc was not received a report that there was patient injury or discontinuance of the procedure.The subject product was returned to omsc for investigation on oct.21, 2016.The investigation confirmed that the cutting wire was broken.The coating on the cutting wire was approximately missing for 9.0mm from the broken point.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: kunimori yamaguchi ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425117
• MDR Report Key: 6059517
• MDR Text Key: 58463637
• Report Number: 8010047-2016-01413
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: KD-V411M-1530
• Device Lot Number: K6411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1