MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. E650001 ELECTROSURGICAL SNARE

Model Number SD-Y0001-U15

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

Patient Problem 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

Olympus medical systems corp.(omsc) received a literature titled "original article endoscopic papillectomy for ampullary adenoma and early adenocarcinoma : analysis of factors related to treatment outcome and long - term prognosis".The literature reported the result of 253 patients with papillary adenoma who underwent endoscopic papillectomy procedure using olympus sd-y-0001 and unspecified stent from january 2002 to march 2020.In the literature, it was reported complication as follows; pancreatitis (mild 15cases, moderate 3cases, severe 1case).Bleeding (mild 21cases, moderate 2cases).Perforation requiring drainage and fasting for several days (7cases).There are not mentioned that these complications were related to the subject device in question.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.However, omsc assumes that "severe pancreatitis" and "perforation requiring drainage and fasting for several days" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.Therefore, omsc determined that the "severe pancreatitis" and "perforation requiring drainage and fasting for several days" were adverse events to submit.Omsc will submit 2 medical device reports (mdrs) depending on the event.This is a report on "severe pancreatitis".

• Brand Name: E650001 ELECTROSURGICAL SNARE
• Type of Device: ELECTROSURGICAL SNARE
• 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: 12451903
• MDR Text Key: 270783562
• Report Number: 8010047-2021-11543
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SD-Y0001-U15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2021
• 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): Other