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

Model Number HX-400U-30

Device Problem Retraction Problem (1536)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/25/2021

Event Type  Injury  

Event Description

The customer reports during a flexible colonoscopy and polypectomy using a polyloop single use ligating device, while removing a pedunculated polyp, the polyloop could not be removed from the patient.An endoloop had been used previously and it malfunctioned and did not detach from the catheter.The physician attempted to use a coagulation grasper to cut the retained device loose with no success.The on-call surgical consult physician was contacted.While the patient was in the recovery room, the surgeon assessed the patient and attempted to remove the retained device with a proctoscope and wire cutter.This too was unsuccessful.The patient was taken to the operating room to have the retained device surgically removed.The patient was observed and remained stable throughout.The patient was made aware of the sequence of events.No additional consequences to the patient were reported.The device was discarded by the customer and cannot be returned for evaluation.

Manufacturer Narrative

This report is being submitted to report information provided by the customer and the investigation findings.The device history records below were reviewed for the reported lot.The review revealed the lot had passed all the event-related inspection items.Process inspection, quality inspection, nonconforming product report.The instruction manual for this device contains following warnings.Do not strike or crush the coil sheath during operation.Doing so can damage the distal end of the coil sheath, which could make it impossible to detach the loop after ligation.In this case, refer to ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.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.In this case, refer to ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.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.In this case, refer to ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.Never use excessive force to operate the instrument.This could damage the instrument.The exact cause of detachment fault of the loop could not be conclusively identified by the following reason; the device was not retuned for the investigation.No abnormalities on the device was considered as no abnormalities were found in the device history record.However, based on the investigation of a past similar case, detachment fault of the loop was likely caused by the mechanisms below.The loop was detached from the hook while the coil sheath was being retracted into the tube sheath, or the loop was hung on to the tissue and it was positionally fixed at the distal end of the tube.As a result, the loop was unable to release.The tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.The pulling of the tube sheath caused the loop to move with the distal end of the tube sheath toward the coil sheath.Subsequently, the loop entered the coil sheath and got caught between the hook and the coil sheath.

• 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: 13195099
• MDR Text Key: 288038049
• Report Number: 8010047-2022-01082
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• 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: V15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Other