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 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During a pedicle polyp polypectomy, the subject device was used.The user put a first endoloop and they had not released it exactly at the height they wanted.They put the subject device secondly.The sheath was completely attached to the polyp and they could not separate it.The handle was broken and did not release the endoloop.They cut the handle, took out the endoscope leaving the sheath coming out of the patient, introduced another device, and tried to release the endoloop and they could take it out of the patient.There was no patient injury reported.No further information was provided.

Event Description

An additional information was reported as follows: the user cut the handle, took out the endoscope leaving the sheath coming out of the patient, introduced the endoscope tube and a polypectomy snare, and trying to place the polypectomy snare between one endoloop and the other, and due to the movements of the polypectomy snare, the sheath was released and they could take it out of patient.

Manufacturer Narrative

This is a supplemental report to provide additional information in b5 and h10.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, we assumed that the handle was broken and the loop could not be removed since the loop was caught between the hook and the coil sheath after the loop was released in the tube sheath for unspecified reason.The above device handling has warned in the instruction manual as follows.Do not remove the loop from the hook while the coil sheath is not extended from the tube sheath.Otherwise, the loop may be tangled with the hook and become impossible to be removed.Do not hold the loop with the distal end of the tube sheath while the loop is surrounding the tissue.Otherwise, when the tissue is ligated, the loop may be detached from the hook in the tube sheath and tangled with the hook.That may make the loop impossible to be removed.Never use excessive force to operate the instrument.This could damage the 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: 9556555
• MDR Text Key: 220344139
• Report Number: 8010047-2020-00819
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HX-400U-30
• Device Lot Number: 91V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1