MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ROTATABLE CLIP FIXING DEVICE; LIGATION CLIP, METALLIC

Model Number	HX-201LR-135L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported, during an (b)(6) 2022 therapeutic emergency procedure to control bleeding for a bleeding bulbar ulcer, the surgeon attempted to control the bleeding with the subject device but it failed.The surgeon controlled the active bleeding by injecting adrenaline and sclerosant (lauromacrogol).The patient was transferred to a level 2 endoscopy facility with emergency service as a precautionary measure to make sure the patient received the most appropriate service.The device was inspected prior to use and no damages identified.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer returned 2 clips and confirmed the 2 clips failed to deploy outside the sheath during this same procedure.This event includes 2 reports: (b)(6): clip 1 (b)(6): clip 2 this report is 1 of 2 for (b)(6): clip 1.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information and corrections.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The customer reported they cut the teflon sheath because it did not expose the metal catheter with the clip attached.The subject device was returned.Inspection was carried out by straightening out the insertion portion.The distal end of the coil sheath extended from the tube sheath when the tube joint was pulled.The clip was not connected to the hook.Inspection was further carried out in accordance with the product standards.Under the following conditions, the subject device was inserted into an olympus test endoscope.The distal end of the coil sheath extended from the tube sheath.Inspection of the distal end of the tube sheath revealed the shape that was cut mechanically using a tool.The location of severed area was inspected by moving the root of the tube sheath to the distal end of the handle.It was confirmed that the severed area was located at 2mm from the distal end.It was confirmed that the hook was detached from the clip when the slider was pushed.The clip was not returned for investigation.The tube sheath did not present any deformation, such as the shape which appears to have been crushed.The customer also returned four unopened devices.Inspection was carried out by straightening out the insertion portion.The clip of all 4 devices did not extend from the tube sheath when the tube joint was pulled.The distance from the distal end of the tube and the distal end of the clip was measured by straightening the insertion portion.The tube sheath was longer than it should be, and it deviates from the product standards.No other abnormalities that could lead to the phenomenon of the reported event could not be confirmed.Since the tube sheath of the device was severed, the exact cause of the reported event could not be determined.However, since this failure occurred in the same lot, the investigation results are based on patient identifier (b)(6).Due to production issues, the tube sheath of the subject device was too long.Therefore, the clip could not be extended from the tube sheath.This event underwent formal investigation by the original equipment manufacturer (oem).The following mechanisms likely caused the production issues: 1) the workload of the manufacturing manager was excessive on the date of manufacture.However, no assistance was provided from superiors.2) operators were changed.However, the workload of the manufacturing manager was excessive, and it was not possible to confirm the operator's job description.3) products were manufactured by operators who were unfamiliar with the product.Or products were manufactured by operators without confirming their work description or receiving work instruction.4) the operator stated above 2) forgot to cut the tube sheath during final assembly process.As a result, the tube sheath became longer.5) during the inspection process, ¿length from the distal end of the tube sheath to the distal end of the clip¿ was not measured.Therefore, the long tube sheath was unnoticed and it was distributed to the market.The oem is implementing preventative measures.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Common Device Name: LIGATION CLIP, METALLIC
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15690956
• Report Number: 9614641-2022-00549
• Device Sequence Number: 6821937
• Product Code: MND
• UDI-Device Identifier: 04953170353147
• UDI-Public: 04953170353147
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K013066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX-201LR-135L
• Device Lot Number: 1ZV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 11/17/2022; 08/30/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 11/29/2022; 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN ENDOSCOPE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown