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

Model Number KD-V411M-0730

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

Patient Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481)

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

On may 10, 2021, olympus medical systems corp.(omsc) received the literature titled "endoclip therapy of post-sphincterotomy bleeding using a transparent cap-fitted forward-viewing gastroscope".This study was conducted on endoscopic retrograde cholangiopancreatography(ercp) with endoscopic sphincterotomy(es) for 1448 patients from january 2011 to december 2015.In the literature, it was reported 57 patients of uncontrolled hemorrhage, and 3 patients of mild pancreatitis.The 57 patients of uncontrolled hemorrhage were 45 patients of early uncontrolled hemorrhage and 12 patients of delayed hemorrhage.All 57 patients with post-es uncontrolled hemorrhage underwent endoclip therapy, and hemostasis was successfully achieved in all patients with early uncontrolled or delayed hemorrhage.However, five patients with delayed hemorrhage required blood transfusions after ercp to remove stones, and one of five patients with severe bleeding received a total of six units of packed red blood cells.Three patients with difficult cannulation developed mild pancreatitis after the procedure and fully recovered with conservative management.Therefore, omsc assumes that the five patients with delayed hemorrhage required blood transfusions was an adverse event to submit due to required blood transfusions.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.Omsc will submit one medical device reports (mdr) of the subject device for five patients with delayed hemorrhage required blood transfusions.

• 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: 11861688
• MDR Text Key: 262885764
• Report Number: 8010047-2021-06589
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: KD-V411M-0730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2021
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other