MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE LIGATING DEVICE

Model Number HX-400U-30

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2021

Event Type  Injury  

Event Description

It is reported during a colonoscopy using a single use ligating device and a colonoscope, the release mechanism malfunctioned and did not deploy as the inner wire broke on attempted deployment.The endoloop remained attached to the polyp base.The physician tried to remove the scope but could not because it was pulling on the large polyp.The physician used a wire cutter to cut below the handle, the sheath was stripped, and the outer coil cut with attempt to manipulate the inner wire or the outer coil with no improvement.The doctor could not determine what was preventing the scope from being removed after the handle was already cut as outlined in the instruction manual¿s emergency procedure.The physician called olympus emergently for potential injury.Troubleshooting steps failed.Olympus advised there is the possibility of open surgery being required to remove the retained endoloop/scope.The physician employed the use of a second endoscopy scope and tower and performed a colonoscopy adjacent to the tethered scope and endoloop.Using cutters, the physician was able to manually cut the endoloop to free up the first endoscope and remove the endoloop wire and sheath that was previously tethered.There was no injury to the patient during these maneuvers, however the case was prolonged and required significant technical effort.The patient's current condition is described as: there was no injury to the patient.The colonoscope did not malfunction in any way.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: SINGLE USE LIGATING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12739421
• MDR Text Key: 279778024
• Report Number: 2951238-2021-00436
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/08/2021,11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: OXV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 73