MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. LONG CLIP

Model Number	HX-610-090L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to olympus that the long clip could not be loaded into the clip applier during an unspecified therapeutic procedure.Five hemostatic clips were used, of which the first 2 functioned correctly, whereas the last 3 clips failed to achieve their function.The user introduced the autoclavable clipper into the blue orifice, then preceded with the opening and traction necessary for fitting, but twice it opened and then moved laterally to the clip, making it impossible to remove from the packaging.On the third attempt, the clipper locked and it detached itself from the tip.The procedure was delayed for 30 minutes and reportedly resulted in moderate bleeding.The procedure was completed and there was no further report of patient harm or injury due to the event.No additional interventions were performed and the procedure was completed.Patient identifier (b)(6) for long clip #1 of the 3 clips that failed in the event.Patient identifier (b)(6) for long clip #2 of the 3 clips that failed in the event.Patient identifier (b)(6) for long clip #3 of the 3 clips that failed in the event.
Additional Manufacturer Narrative
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, correction the initial with information inadvertently left out, and to provide additional information received through follow-up.The subject device was manufactured in march 2022, but the specific date is unknown.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the phenomenon of the bleeding due to procedural delay occurred due to the clip could not be loaded into the applicator.The root cause could not be determined.Additionally, the phenomenon of clip could not be loaded into the applicator is likely due to the wing of the holding tube was caught on the tip of the coil sheath and the clip could not be loaded into the applicator.However, the root cause could not be identified.The event can be prevented by following the instructions for use which state: "·squeeze and hold the cartridge grip until the clip is fully loaded.Also, keep the coil sheath straight against the cartridge while loading the clip.If the grip is loosened or the coil sheath is tilted, the position of the tip of the coil sheath will shift and a gap will be created, making it impossible to load the clip.·do not push the slider forward more than necessary.It may lead to breakage of the clip" olympus will continue to monitor field performance for this device.
Event or Problem Description
B5:the customer confirmed: the malfunction in one of the clips, was that when opening the clipper, it slipped, getting stuck in the cartridge (it was not possible to pull it back).In the others, the clip was fitted, but when pulling to pull the clip, it also got stuck.The clip was used to try to stop the bleeding.In other words, the cause of the bleeding was not caused by the use of the clip.The product did not break and/or did not remain in any cavity of the patient.No harm to the patient and/or user.The procedure was a therapeutic procedure called a settler with mucosectomy.

• Brand Name: LONG CLIP
• Common Device Name: LONG CLIP
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16358772
• Report Number: 9614641-2023-00203
• Device Sequence Number: 6432427
• Product Code: PKL
• UDI-Device Identifier: 04953170200373
• UDI-Public: 04953170200373
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K183590
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX-610-090L
• Device Lot Number: 23K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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: LONG CLIP (HX-610-090L); LONG CLIP (HX-610-090L)
• Patient Sex: Unknown