MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number KD-V411M-0725

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Peritonitis (2252); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

Event Description

Olympus reviewed the following literature: permanent endoscopic gallbladder stenting versus removal of gallbladder drainage,long-term outcomes after management of acute cholecystitis in high-risk surgical patients for cholecystectomy:multi-center retrospective cohort study" by a.Maruta, t.Iwashita, and keisuke iwata et al.    endoscopic transpapillary gallbladder drainage (egbd) has been reported as an effective gallbladder drainage treatment option for acute cholecystitis in high-risk surgical patients.However, the long-term outcomes such as cholecystitis' recurrence rate after placement of egb stenting (egbs) have not been well studied yet.The authors used 3 olympus devices and did not specify the adverse events in relation to the devices and therefore, the adverse events will be reported for all olympus devices (b)(6): kd-v411m-0725.(b)(6): kd-211q-0725.Complaint 3 visiglide2.1 - pancreatitis.1 - cystic duct injury, managed conservatively.3 - bile peritonitis, managed conservatively.Late adverse events (6 months and 1 year).22 - cholecystitis reoccurrence.11 -common bile duct stones.3 - common bile duct stones and reoccurrence of cholecystitis.This is report 1 of 3 for (b)(6): kd-v411m-0725.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• 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: 13603579
• MDR Text Key: 290770232
• Report Number: 8010047-2022-03598
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170184031
• UDI-Public: 04953170184031
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0725
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: VISIGLIDE2
• Patient Outcome(s): Other