MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION/ OLYMPUS SURGICAL TECHNOLOGIES AMERICA LOOP CUTTER; ENDOSCOPIC GRASPING / CUTTING INSTRUMENT, NON-POWERED EXEMPT

Model Number FS-5U-1

Device Problems Break (1069); Migration or Expulsion of Device (1395); Therapeutic or Diagnostic Output Failure (3023); Physical Resistance/Sticking (4012)

Patient Problem Extubate (2402)

Event Date 05/31/2019

Event Type  Injury  

Event Description

Admitted for esophageal stent placement.Stent placed (b)(6) 2019 in endo, pt 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 pt intubated and transfer to micu.Pt 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.Fda safety report ids# (b)(4).

• Brand Name: LOOP CUTTER
• Type of Device: ENDOSCOPIC GRASPING / CUTTING INSTRUMENT, NON-POWERED EXEMPT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION/ OLYMPUS SURGICAL TECHNOLOGIES AMERICA
• MDR Report Key: 8817630
• MDR Text Key: 152068654
• Report Number: MW5088292
• Device Sequence Number: 2
• Product Code: PTS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/18/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FS-5U-1
• Device Lot Number: 93K
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 68