MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. LOOP CUTTER

Model Number	FS-5U-1
Health Effect - Clinical Code	Edema (1820)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The service center received a medwatch mw5088292 report which states, " admitted for esophageal stent placement.Stent placed (b)(6) 2019 in endo, patient taken back the following day for stent repositioning since stent had migrated out of place.Md documents in procedure note there were multiple equipment malfunctions causing the procedure to take longer than normal.Md was concerned for airway edema, decision was made to leave patient intubated and transfer to micu.Patient was extubated (b)(6) with no complications and later transferred to the 7th floor.This is a disposable valve used to activate suction through the endoscope.Malfunction event: valve became stuck and broken when tech attempted to remove from scope during the procedure.A new endoscope had to be brought in to continue with case.This is a reusable device but it was brand new when tech opened for use.¿.

• Brand Name: LOOP CUTTER
• Common Device Name: LOOP CUTTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8966156
• Report Number: 2951238-2019-01104
• Device Sequence Number: 11287517
• Product Code: PTS
• UDI-Device Identifier: 04953170033445
• UDI-Public: 04953170033445
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/05/2019
• Report Date (Section F): 09/05/2019

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: FS-5U-1
• Device Lot Number: 93K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEFENDO SUCTION VALVEMODEL# 100305LOT# 415963
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 09/05/2019