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

Model Number HX-400U-30

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.

Event Description

The service center received a report of a single use ligation device, model hx-400u-30, lot number 89v, whose handle broke during a procedure.The ligating device was inspected prior to the procedure and no anomalies were observed.A physician was using the ligation device during therapeutic colonoscopy procedure and the loop was attached to a polyp when the handle broke.The physician could not release the loop from the device and had to cut the loop in order for it to be removed from the patient.The exposed handle wire had to be strung through the endoscope and the scope reinserted.No part of the device fell into the patient.It was reported that due to the incident, the patient was under additional anesthesia for 30-60 minutes, as needed.The type of anesthesia was monitored anesthesia care (mac).It was reported no further medical intervention was needed for the patient and the procedure was completed as intended.It was reported there was no patient death or injury.It was reported the device is being returned to the service center for evaluation.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation.The service center received a single use ligating device (model hx-400u-30), lot number 89v, for the evaluation that the handle broke.The hx-400u-30 device was visually inspected and observed to be received damaged; the handle portion was detached from the insertion portion tubing wire.The detached handle was not returned to the service center for evaluation.The insertion portion was inspected and two kinks were observed near the yellow tube joint.One of the kinks had a cut exposing the inner wire.The distal end was inspected and foreign discoloration was observed.Based on the evaluation of the returned device, the user¿s complaint was confirmed, and the determined cause for the detached handle was due to excessive force.The instructions for use states, ¿do not advance or extend the instrument abruptly.This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It could also damage the endoscope and/or instrument.¿.

• 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: 9706282
• MDR Text Key: 221595376
• Report Number: 8010047-2020-01328
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 89V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1