MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. LIGATING DEVICE; LIGATION DEVICE

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed by the health professional that the following event occurred.The colorectal polyp was resected and hemostasis was done with a clip, but it was not enough.Therefore, the subject device was used to prevent bleeding.The user moved the device handle back and forth but was not able to remove the loop from the sheath.The user cut the sheath at the proximal side with pliers and tried to remove, but was not able to remove it.The user tried another method, such as using an electrosurgical snare, but was unable to remove the loop.The user could not use the loop cutter since the distal end of the sheath is close to the loop stopper.The user decided to leave the loop in place until tissue necrosis occurs and the loop and tissue come free.The device was able to be removed naturally from the patient the next day.The intended procedure was completed with the subject device.

Manufacturer Narrative

This is a supplemental report to provide additional information.The following additional information was provided.*the subject device was reusable device.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the event date, it was found no irregularities.Based on the past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.1.When the loop was detached from the hook, it was either the coil sheath was retracted into the tube sheath, or the distal end of the tube sheath was pressed against the tissue with the loop being snared to the tissue.2.The tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.3.When the tube sheath was pulled to the proximal side, the loop pulled the tube, and it was retracted into the coil sheath.As a result, the loop became intermeshed in between the hook and inside the coil and stopped moving.This caused the device to become impossible to be removed.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 become impossible to be removed.

• Brand Name: LIGATING DEVICE
• Type of Device: LIGATION DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11722644
• MDR Text Key: 247753784
• Report Number: 8010047-2021-05374
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization