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

Model Number	FS-5U-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to the service center for evaluation.Due to insufficient information regarding the use of the equipment during the procedure the cause of the reported event cannot be determined.An investigation is ongoing to obtain more detailed information regarding the reported events.
Event or Problem Description
The service center received a medwatch 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.Mm 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: 8966189
• Report Number: 8010047-2019-03198
• Device Sequence Number: 16681971
• Product Code: PTS
• UDI-Device Identifier: 04953170033445
• UDI-Public: 04953170033445
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention