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

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "evaluation of the safety and efficacy of minimal endoscopic sphincterotomy followed by papillary balloon dilation for the removal of common bile duct stones".The literature reported the result of 435 patients with common bile duct (cbd) stones who underwent endoscopic sphincterotomy procedure using the olympus clever cut 3v and non-olympus device from january 2009 to december 2018.In the literature, it was reported complication as follows: post-ercp pancreatitis (9 cases); early bleeding (12 cases): these patients with early bleeding required unplanned hospital admission or prolongation of hospital stay; delayed bleeding (3 cases); perforation (3 cases); acute cholangitis (4 cases); acute cholecystitis (4 cases); and recurrence of cbd stones (32 cases).There are not mentioned that these complications were related to the subject device in question.However, omsc assumes that "early bleeding" and "perforation" might be related to "clever cut 3v" due to the procedure using "clever cut 3v".Omsc assumes that the "early bleeding" was serious injury due to required unplanned hospital admission or prolongation of hospital stay.And, there is no detailed description of the "perforation".However, omsc assumes that "perforation" was might be caused or contributed to a death or serious injury.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.Therefore, omsc assumes that the "early bleeding" and "perforation" were adverse events to submit.Omsc will submit two medical device reports (mdrs) of the subject device for the "early bleeding" and "perforation".This report is for "early bleeding".

• 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: 12251129
• MDR Text Key: 268358567
• Report Number: 8010047-2021-09550
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2021
• 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
• Patient Outcome(s): Hospitalization