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

Model Number SD-210U-25

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

Patient Problems Abdominal Pain (1685); Bowel Perforation (2668)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed territory manager endotherapy of of olympus europa se & co.Kg (oekg) that a few hours after having been discharged from the hospital after a therapeutic polypectomy procedure in the cecum where a polyp of about 1.5 cm was removed, the patient felt pain and returned to the hospital.An intestinal perforation was detected and an emergency surgery was performed where a part of the colon was removed.There were no reports of any malfunction of any of the olympus devices used during the initial procedure.No further information was provided.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc).Therefore, the condition of the device could not be confirmed.Content of the instruction manual (drawing number: gk4000, revision number :27) was confirmed.The instruction manual contains the following descriptions, and it warns against this event.- do not use excessive force when snaring tissue.This could cause patient injury, such as hemorrhages or mucous membrane damage.- do not snare tissue with excessive force.This could break the snare loop, which could cause patient injury such as punctures, hemorrhages, or thermal injury to non-target tissue from mechanical resection.- always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as punctures, hemorrhages or mucous membrane damage.- when applying the current, do not use an excessive amount of conduction.Doing so could cause patient injury such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure.Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.Since the subject device lot number was unknown, the dhr for over the past year prior to the date of occurrence was inspected.No abnormalities found in the dhr of the following items which relate to the reported phenomenon.- dc resistance value - opening width of the loop - operation force - appearance complaint occurrence of the same product and the same phenomenon was investigated.However, there have been no similar reports with the subject device.The subject device could not be confirmed.There were no abnormalities in the dhr, and there have been no similar reports with the subject device.Therefore, a likely factor causing perforation might be the following.However, the exact cause of the reported event could not be confirmed.- tissue that is not the target of the resection (such as muscle layer) has been snared and resected.- the output during energization was high - energizing time was long - condition of patient¿s tissue.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: DISPOSABLE ELECTROSURGICAL SNARE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11781476
• MDR Text Key: 264516473
• Report Number: 8010047-2021-05913
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• PMA/PMN Number: K902735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-210U-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention