MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ROTATABLE CLIP FIXING DEVICE

Model Number HX-201UR-135L

Device Problem Misfire (2532)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report the event and investigation results.The complaint devices could not be physically evaluated by olympus as they were discarded by the customer.A review of the device history record for the devices was conducted, and it was concluded that there were no abnormalities in manufacturing that could have contributed to the reported phenomenon.A review if the instructions for use for the complaint device provides the user the following warnings related to the reported event: do not force the clip against body cavity tissue.The clip may be deformed and does not close properly.This could result in reduced performance.Do not withdraw the instrument or change the angulation of the endoscope when clipping is not completely finished (when the slider is not pulled to the end).Doing so may tear tissue inside the body cavity, resulting in patient injury, such as punctures, hemorrhages or mucous membrane damage.If the clip cannot be removed from the distal end of the coil sheath, push the slider forward.Confirm that the slider is pulled when the clip is removed.Conclusion: the subject device was not returned for investigation.Therefore, the definitive cause of the reported event could not be identified.However, likely causes of the reported event include the following: sliding resistance of the operation wire and coil sheath increased due to the angle of the scope, or the shape of the insertion portion.If the slider could not be pulled completely, the clip could not properly deploy.In this device, the clip pipe which affixes the clip on the clip side contains silicon.If the silicon got caught on the hook of the connecting board, it could lead to the reported event.This event has been reported by the importer on mdr (b)(4).

Event Description

It is reported in user facility med watch ((b)(4)) and follow-up information provided by the customer, during an emergent repair of a gastrointestinal (gi) bleed, a single use rotatable clip fixing device failed to detach when fired (reported in case with patient identifier (b)(6)).This caused the tissue to tear and increased bleeding to occur.A second clip was deployed, and it also failed to detach appropriately (reported in case with patient identifier (b)(6)).Two other clips were test fired into a blanket and those failed to detach appropriately (this report, and case with patient identifier (b)(6)).Additional details and series of events as follows: at the beginning of the procedure, irrigation was performed, removing a clot.This revealed a slow pulsating bleed.Attempted to control bleeding with clip- clipping device malfunctioned.One clip fired but did not detach from the device.This caused the tissue to tear and increased bleeding to occur.The surgeon attempted to place another clip, but the same thing happened.At that point the patient started to bleed briskly.A second surgeon was called in to assist.The second surgeon did not attempt to place any more clips because he did not want to lose control of the vessel again the surgeons attempted to try a heat probe to control the bleeding without success.The area was ultimately injected with epinephrine until the bleeding was controlled.Hemospray was then applied on top.It was determined that the epinephrine and hemospray held to allow enough time to get patient transferred out to a different facility since patient still needed a more permanent method to control the bleeding.The patient was transferred to another facility for a higher level of care.Follow-up information received from subsequent facility.They performed urgent endoscopy at the bedside.One previously placed clip was noted at the base of the ulcer adjacent to the visible vessel.They attempted four times to place clips (unspecified manufacturer) at the base of the visible vessels, only one clip attached, and the other 3 clips spontaneously dislodged after application.The necrotic material on the surface of the visible vessel sloughed off as the clips dislodged after deployment.The clips were not holding as there was no mucosa for them to get an anchor to hold on.Procedure was paused to give the patient a break, then resumed the endoscopy.The physicians noted two dislodged clips which had moved back to the stomach.To prevent aspiration, the two clips were grasped with forceps and moved back to the duodenum.The scope was advanced and again the physicians noted active pulsatile bleeding from the visible vessel.The decision was made at that time to take the patient to emergent surgery because the active arterial bleeding was not amenable to endoscopic control.Interventional radiology (ir) was contacted, and embolization was determined to be the appropriate intervention.The patient's current condition could not be provided by the customer (since they were transferred out of their facility).The complaint devices will not be returned to olympus for physical evaluation.They were discarded by the customer.

Manufacturer Narrative

This report is being updated to provide additional investigation findings.Replication testing was carried out in four different testing conditions in an effort to replicate the user's report.The user's report could be replicated, however, upon review of the complaint history, there have been no similar reports.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Type of Device: SINGLE USE ROTATABLE CLIP FIXING 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: 11094823
• MDR Text Key: 231423170
• Report Number: 8010047-2020-11136
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170353161
• UDI-Public: 04953170353161
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-201UR-135L
• Device Lot Number: 98V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2021
• 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): Other; Required Intervention