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

Model Number	HX-201UR-135
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H4: the subject device was manufactured in july 2021 based on the provided july digit lot information "17".The manufacture date cannot be identified since the subject device has only 3 digit lot information.The device was discarded at the end of the procedure and was not available to be evaluated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation results, the clip didn¿t get loose after attaching to the colon closing the forceps.The root cause of this reported event was unable to be identified.The instructions for use (ifu) states the following: do not coil the insertion portion with a diameter of less than 20 cm.This could damage the insertion portion.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 try to forcibly remove the clip if it becomes caught on the distal end of the coil sheath.Forcible removal of the clip could cause patient injury such as punctures, hemorrhages or mucous membrane damage.Olympus will continue to monitor field performance of this device.
Event or Problem Description
The customer reported to olympus ezclip didn¿t get loose after attaching to the colon closing the forceps (were at the highest point in the colon).The user had to open and close several times.The intended procedure was colonoscopy polyp removal and was completed with another ezclip.The patient was not under anesthesia.There were no reports of patient harm or impact associated with this event.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Common Device Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18630750
• Report Number: 9614641-2024-00236
• Device Sequence Number: 7834460
• Product Code: PKL
• UDI-Device Identifier: 04953170193026
• UDI-Public: 04953170193026
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• PMA/510(K) Number: K013066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

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-201UR-135
• Device Lot Number: 17
• 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: 07/10/2023
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown