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

Model Number FS-5U-1

Device Problems Break (1069); Migration or Expulsion of Device (1395); Physical Resistance/Sticking (4012)

Patient Problem Edema (1820)

Event Date 05/31/2019

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 156655740
• Report Number: 2951238-2019-01104
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 04953170033445
• UDI-Public: 04953170033445
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FS-5U-1
• Device Lot Number: 93K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2019
• Distributor Facility Aware Date: 08/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DEFENDO SUCTION VALVEMODEL# 100305LOT# 415963
• Patient Outcome(s): Hospitalization; Required Intervention