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

Model Number HX-400U-30

Device Problem Misfire (2532)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/06/2022

Event Type  Injury  

Event Description

The customer reports during an unspecified procedure using a single use ligating device, the loop did not deploy properly and snipped the top of the polyp, then retracted into the sheath.This led to bleeding that had to be controlled with the use of an endoscopic clip.No additional consequences to the patient have been reported.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.Preliminary finding are reported.The investigation is ongoing.Physical examination of the suspect device: visual inspection as received condition found the outer sheath had moved and covered the distal section with loop retreated inside the sheath.There is biomaterial inside the sheath consistent with use.Olympus observed that the loop stopper (a plastic shrinking tube covering the proximal end of the loop) was separated from it.However, when olympus moved the yellow tube joint toward the handle, the loop came out from the tube sheath.The loop was inspected under a microscope and found no abnormality on the appearance.The coil sheath and outer sheath also appeared to be normal.The slider is operational, but a slight restriction could be felt while pushing to extend the j hook at the distal end.Based on the evaluation finding, olympus confirmed loop retracted into the sheath.Per the instructions for use (ifu) shipped with the device: do not pull the slider before surrounding the target tissue with the loop.Otherwise, the loop stopper would be dislodged.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.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00456.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being updated to provide additional information reported by the customer.

Event Description

Update: additional information reported by the customer: the procedure being performed was a colonoscopy with polypectomy for the indication of rectal bleeding of unknown etiology.The total blood loss for the entire procedure was noted on the operative report to be 5ml.From the operative report, hemostasis was achieved with 2 hemoclips (no additional mentioned interventions needed).The patient has no known long term complications for this event.There were no anatomical or procedural challenges noted in the operative report.The customer did not answer the question :did he scope used concomitantly in the procedure malfunction?.

Manufacturer Narrative

This report is being updated to provide investigation findings.Physical evaluation of the returned device: olympus received one single use ligating device model hx-400u-30, physical lot# 99v 25, for evaluation due to the report of: loop not being deployed properly and snipped the top of the poly and retracted into the sheath.Visual inspection as received condition found the outer sheath had moved and covered the distal section with loop retreated inside the sheath.There is biomaterial inside the sheath consistent with use.Mq observed that the loop stopper (a plastic shrinking tube covering the proximal end of the loop) was separated from it.However, when olympus moved the yellow tube joint toward the handle, the loop came out from the tube sheath.The loop was inspected under a microscope and found no abnormality on the appearance.The coil sheath and outer sheath also appeared to be normal.The slider is operational, but a slight restriction could be felt while pushing to extend the j hook at the distal end.Based on the evaluation finding, olympus confirmed loop retracted into the sheath.The dhr with the lot number of the subject device was confirmed.No abnormalities detected in the dhr for the following items which related to the reported phenomenon.·process inspection sheet ·quality inspection sheet ·nonconforming product report the instruction manual shipped with the device contains following warnings: ¿ do not apply unnecessary force to the loop when ligating tissue during the procedure.Excessive force applied to the loop could cut the surrounding body cavity tissue, resulting in patient injury, such as hemorrhages or mucous membrane damage.It may also damage the endoscope and/or instrument.¿ do not pull the slider before surrounding the target tissue with the loop.Otherwise, the loop stopper would be dislodged.[conclusion summary].Based on the investigation result, a likely mechanism causing the reported phenomenon might be the following: 1.The loop was secured around the polyp.2.The slider was mistakenly pulled, and the loop cut the polyp.This caused bleeding.3.The loop was completely retracted into the coil sheath causing the loop stopper to detach.However, the exact cause of the problem could not be determined.

• 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: 14961213
• MDR Text Key: 295599987
• Report Number: 8010047-2022-11641
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• 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: 99V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: PCF-H190L, SN (B)(6)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 68 KG