MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number HX-202UR

Device Problem Difficult to Remove (1528)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/04/2023

Event Type  malfunction  

Event Description

An olympus representative reported to olympus, on behalf of the customer, that the single use repositionable clip did not deploy after it had grabbed the tissue during an unknown procedure.The clip had to be forcibly removed, which caused a small tear in the mucosa.Attempts to obtain additional information was performed but no further information was available.The non-deployment of clips occurred 3 times; at least once resulted to a small mucosal tear while the other 2 instances did not.These incidents are captured under the following patient identifiers: (b)(6).

Manufacturer Narrative

The lot number of the device referenced in this report is unknown, and it is unknown if the device will be returned to olympus.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus representative reported that the mucosal tear was not severe and no significant bleeding was noted.Another clip was placed in the area to close the tissue after the first one failed to deploy.There was no delay in the procedure nor was there any additional medical or surgical intervention done as a result of the reported event.

Manufacturer Narrative

This report is being submitted due to the additional information received that is reflected in b5.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The specific root cause of the reported problem could not be determined at this time because the device was not returned.The following information is stated in the instructions for use (ifu): ¿·operation of this instrument is based on the assumption that open surgery is possible as an emergency measure if the clip cannot be detached from the instrument or if any other unexpected circumstance takes place.In this case, refer to chapter 14, ¿emergency treatment¿.·do not withdraw the instrument forcibly or change the angulation of the endoscope when the clip is grasping the tissue and is not released.Doing so may tear tissue inside the body cavity, resulting in patient injury, such as perforation, bleeding, or mucous membrane damage.·do not angulate the bending section of the endoscope or withdraw the instrument from the endoscope while the clip is grasping the tissue before being released.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.·do not try to forcibly withdraw the instrument from the endoscope if the clip cannot be detached from the instrument.Forcibly withdrawing the instrument could cause patient injury such as perforation, bleeding, or mucous membrane damage.·should the slightest irregularity and/or breakage of the parts be suspected, withdraw the instrument from the endoscope immediately according to the steps of ¿withdrawing the instrument from the endoscope¿ on page 10.Otherwise, perforation, bleeding, or mucous membrane damage may result.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: SINGLE USE REPOSITIONAL 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: 16270392
• MDR Text Key: 308448773
• Report Number: 9614641-2023-00133
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2023

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
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 02/06/2023; 08/30/2023
• Supplement Dates FDA Received: 02/24/2023; 08/31/2023
• 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