MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)

Model Number KD-VC611Q-07201S

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Laceration(s) (1946)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus.The cause of the reported event could not be determined at time.In addition, insufficient information regarding the reported device, patient and procedure was reported.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event.If additional information becomes available, this report will be updated and supplemented accordingly.

Event Description

Olympus was informed that during an endoscopic retrograde cholangiopancreatography (ercp) procedure, the device did not bow at the tip but instead the catheter contorted at the handle.The patient was cut in the wrong area.No additional cut was performed the doctor was able to complete the procedure using the existing cut.The procedure was completed but not the way it was intended.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the user facility.The user facility further reported that the patient's ampulla was cut while the doctor was performing a sphincterotomy.Instead of cutting the ampulla straight up, the tome moved to the left.The doctor stopped the sphincterotomy immediately, and the tome was inspected.It was then observed that the tome was bending at the handle.There were no issues inserting or withdrawing the tome from the patient.There was also no unusual behavior from the equipment used during the procedure.No device components broke off.The procedure was not delayed.It was also reported that prior to the reported event, the doctor had intended to dilate the ampulla after sphincterotomy.After the reported event, the doctor used an extraction balloon to sweep the patient¿s bile duct.The doctor decided use a different tome as a result of the unintended cut.The same scope was used throughout the procedure without issue.The tome packaging was opened and inspected prior to the procedure and no issues were noted.However, the bow was not checked.The patient was discharged, however, no information was provided regarding any additional treatment to the patient or if the patient required a longer stay.

Manufacturer Narrative

This supplemental report is to provide additional information from the original equipment manufacturer.The cause of reported event cannot be conclusively determined as the reported device was not returned.However, based on similar complaints related to the reported device, the most probable cause of the reported event could be attributed to the one of the following: mechanism below could have caused the phenomenon.A part of the sphincterotome tube remaining outside the endoscope¿s biopsy valve became bent near the proximal/handle.If the slider was pulled while resistance is felt between the cutting wire inside the tube and the bent part of the tube.The increased sliding resistance prevented the distal end of sphincterotome from bowing.The increase instead caused the tube to move back with the cutting wire drawn by the slider.The tube as a result compressed and twisted near the handle.As part of the investigation, a dhr review was conducted for the reported lot number and no deviations or non-conformities were noted during the manufacturing process.The mitigate the risk of patient injury and or equipment damage, the instruction manual provides warning which states, do not force the instrument if resistance to insertion is encountered.Reduce the angulation or lower the forceps elevator of the endoscope until the instrument passes smoothly.The use of excessive force could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.If any resistance is felt or if the tip¿s behavior and/or location seems improper, stop manipulating the guidewire and/or endotherapy accessory and determine the cause by fluoroscopy or the endoscope.Continuing to manipulate the guidewire could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It may also damage the endoscope, guidewire, and/or endotherapy accessory.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Type of Device: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7980422
• MDR Text Key: 124185160
• Report Number: 2951238-2018-00625
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K141991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-VC611Q-07201S
• Device Catalogue Number: KD-VC611Q-07201S
• Device Lot Number: 83V
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other