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

Model Number	HX-610-090S
Medical Device Problem Codes	Device Reprocessing Problem (1091); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus the short clip was stuck inside of the forceps channel.The reported issue was discovered during a diagnostic lower endoscopy procedure.The customer indicated that clips were not used during this procedure and that the last time the clip was used in the endoscope was during procedures on (b)(6) 2023.The procedure was subsequently completed with a similar device.There was no patient/user harm or injury reported due to the event.
Additional Manufacturer Narrative
At this time, it has been indicated to olympus that the device will not be returned for testing and evaluation.Should additional information become available, or the evaluation is completed, a follow-up report will be submitted.Related complaints: (b)(6) cf-h290i evis lucera elite colonovideoscope, serial number (b)(6).(b)(6) hx-610-090s short clip, lot number unknown.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to h6 product problem and h8.Also a correction to b5 for information inadvertently left out.The device history record (dhr) was unable to be reviewed for this device since the lot number was not provided.However, olympus reviewed dhrs for lot numbers which were manufactured one year before the event date and there were no deviations that could have caused or contributed to the reported issue.Since the subject device could not be confirmed, and no abnormalities were detected in the dhr, the exact cause could not be determined.Based on the results of the investigation, the event was likely caused by the following factors: ·when inserted into the scope's forceps channel, the clip fell out because it protruded inside the scope.·when inserted into the scope's forceps channel, a clipping movement occurred within the scope, causing the clip to break and fall off.The event can be prevented by following the instructions for use which state: ·"once the clip is placed inside the coil sheath, do not poke it out of the coil sheath until you are ready to use it.If it sticks out, it cannot be inserted into the endoscope.·when inserting the rotating clip device into the endoscope, hold the slider firmly.If the slider is not held, the rotating clip device may suddenly protrude from the tip of the endoscope, leading to perforation, major bleeding, mucosal damage, or damage to the endoscope or rotating clip device.·do not make sudden protrusions.It may lead to perforation, heavy bleeding, mucous membrane damage, etc., and may lead to damage to the endoscope or rotating clip device.·do not insert the rotating clip device into the endoscope unless the clip is completely retracted into the coil sheath.It may lead to perforation, heavy bleeding, mucous membrane damage, etc., and may lead to damage to the endoscope or rotating clip device.·do not pull the slider suddenly.The clip opens all at once and then closes." olympus will continue to monitor field performance for this device.
Event or Problem Description
The suction button was replaced because it became difficult to suction during the procedure when it was discovered that a clip was stuck inside of the channel.

• Brand Name: SHORT CLIP
• Common Device Name: SHORT 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: 17575608
• Report Number: 9614641-2023-01185
• Device Sequence Number: 8267684
• Product Code: PKL
• UDI-Device Identifier: 04953170200335
• UDI-Public: 04953170200335
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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-610-090S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CF-H290I, EVIS LUCERA ELITE COLONOVIDEOSCOPE
• Patient Sex: Unknown