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

Model Number	SD-210U-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	02/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: concomitant devices: esg-100 generator, single use injector (nm-400u-0423), olympus 260 series scope.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
The customer reports, three days after a colonoscopy procedure using a disposable electrosurgical snare (with an esg-100 generator, nm-400u-0423, and series 260 scope) , the patient presented at another hospital for a bowel perforation.It is unknown what treatment the patient required as a result of the perforation.The patient's current condition could not be provided.There is no report of any device malfunction during the procedure.When the event was was reported, the customer was unsure if there have been an electrical surge that had affected the equipment and wanted it evaluated.An olympus field service engineer (fse) evaluated the esg-100 generator on site and found no issue.Case with patient identifier (b)(6) reports the disposable snare used in the procedure (this report).Case with patient identifier (b)(6) reports the generator used in the procedure.Case with patient identifier (b)(6) reports the single use injector used in the procedure.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.New information is reported in h6 and h10.Physical evaluation of the suspect device could not be conducted as the device was not returned to olympus.The device history records below were reviewed for lots manufactured one year prior to the event date since the lot number of the suspect device was not provided.The review revealed the lots had passed all the inspections relating to the reported incident.Process inspection sheet.Quality inspection sheet.Nonconforming product report.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: ·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.Conclusion: the definitive cause of the reported events could not be established.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Common Device Name: DISPOSABLE 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: 13770634
• Report Number: 8010047-2022-04446
• Device Sequence Number: 20091796
• Product Code: FDS
• UDI-Device Identifier: 04953170036941
• UDI-Public: 04953170036941
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K902735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SD-210U-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown