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

Model Number HX-400U-30

Device Problem Separation Failure (2547)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.As the evaluation is in progress, the exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from user facility that the snare could not be released during a hemostatic associated with polyp resection procedure.The snare and sheath remained in the patient's body.The user facility states as follows, - no surgical procedure will be performed, and the polyp will be necrotic and spontaneously shed to remove the remnants.- tried the method in the instruction manual (below), but could not release it."the slider was pressed with the insertion tube of endoscope and the insertion part of the subject device in question as straight as possible." - attempted to cut the gap in the stopper section using a loop cutter, but could not do so.

Manufacturer Narrative

This supplemental report is being submitted to withdraw mfr report #8010047-2021-16491.The facility provided the following additional information regarding the action.*the loop could not be released.*the insertion portion was severed near the operating portion.*the coil sheath (including the operating wire) could be withdrawn.However, the loop and the tube sheath could not be detached.*the tube sheath that was coming out from inside the body (anal) was further severed.*later, the sheath and loop spontaneously fell off from the polyp and were retrieved.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The subject device was returned prior to its sheath and loop collection.The insertion portion was severed near the operating portion.The broken area of the insertion portion reveals the condition of the severed area.The shape indicates that the area was severed by using a tool.The operating wire and the hook were protruded from the distal end of the insertion portion.The loop was not returned for investigation.The total length of the returned tube sheath was measured.The tube sheath length was 200 mm shorter than usual.The total length of the coil sheath presented no abnormalities.Olympus concluded that there was no mdr reportable malfunction or adverse event.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13050667
• MDR Text Key: 286042336
• Report Number: 8010047-2021-16491
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 14K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1