MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number KD-V431M-0720

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection was performed on the received device and found the cutting wire broke off.Both sides of the broken wire were matched to each post and measured 20 mm in length; therefore, no portion was missing or suspected to be lost.Due to the returned condition of the device wire no further testing could be performed.The sphincterotome v instruction manual gives the user several warnings to mitigate this type of device damage.The ¿operation ¿section of the manual states ¿since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong.When the wire breaks off its proximal end it will retract towards the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or move sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct and/or damage of the endoscope could result.¿.

Event Description

Olympus was informed that during an unspecified procedure sphincterotome v cutting wire broke.There was no report of the device fragment falling into the patient.The generator settings were effect 2/ cut 2 and valve 3.The intended procedure was completed with a similar device.There was no patient injury reported.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: SINGLE USE 2-LUMEN SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8049030
• MDR Text Key: 126650004
• Report Number: 2951238-2018-00684
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170380631
• UDI-Public: 04953170380631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V431M-0720
• Device Catalogue Number: KD-V431M-0720
• Device Lot Number: 83V 08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2018
• 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