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

Model Number KD-V411M-0320

Device Problems Break (1069); Melted (1385)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device kd-v411m-0320 was returned for evaluation. The lot number was 1xk with supplementary information number of ¿01¿. (m-bc manufacture date: october 1, 2021) device evaluation, the following were noted: the cutting wire was broken. The broken portion was scorched and melted. The outer diameter of the cutting wire was measured. The result indicated no abnormalities. The length of the coated portion of the cutting wire, and the cutting wire itself presented no abnormalities. There were no missing parts in the subject device. Other abnormalities that could lead to the breakage of the cutting wire were not confirmed. The dhrs (device history records) for this product have been reviewed. No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon. Length of cutting wire, length of coated portion, operation of cutting wire. The instruction manual (drawing no. Gk6224, revision no. 8) contains the following information. Therefore, it would be possible to prevent this event from occurring. 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 will be retracted toward 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. Be sure that the rear end of the cutting wire is extended from the distal end of the endoscope. In case the cutting wire contacts the forceps elevator, insufficient output or unintended tissue injury may occur. Do not activate output while the cutting wire touches the metal parts of the endoscope, or they are being close together. This could burn the tissue and/or damage the endoscope or the instrument. Investigation is ongoing. This report will be supplemented accordingly following investigation completion.

Event Description

It was reported that the knife broke during an est (endoscopic sphincterotomy) procedure. It is unknown whether or not it involves energization. The device was replaced with similar device and the intended procedure was completed. There was no patient harm or injury reported due to the event. No user injury reported. Device evaluation found the coated portion of the cutting wire was torn, and the broken portion was scorched and melted. This report is being submitted for the coated portion of the cutting wire was torn, and the broken portion was scorched and melted (knife wire breakage when energized) found during device return evaluation.

• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13781446
• MDR Text Key: 287274755
• Report Number: 8010047-2022-04502
• 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: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: KD-V411M-0320
• Device Lot Number: 1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial