MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number	HX-202UR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of our investigation, olympus followed up with the user facility to obtain more information and to clarify if the device broke inside the patient but no information was obtained.The suspected clip was not returned to olympus, however, the user facility returned three brand new devices for evaluation.The devices were received in its original package.A visual inspection was performed on 1 of 3 devices and no problems were found with the device.The distal tip was checked and noted the function of the clip is working normal.The handle was manipulated; the movement is consistent and smooth.The clip was observed during the manipulation as well and the clip was able to deploy properly.The insertion portion and outer sheath was inspected and no signs of damages.The tube joint (yellow) was checked; no physical damages noted.The cause of the reported event could not be determined as the suspected device was not returned.In addition, the evaluation of the new device found the device to be fully functional with no abnormalities.Based on similar reported events related to the reported device, the operator¿s technique cannot be ruled out as a contributory factor.The instruction manual provides warning to mitigate the risk of patient injury and device damage that states, ¿keep the insertion portion of the instrument that extends from the biopsy valve and the insertion portion of the endoscope as straight as possible.Do not perform clipping with the insertion section being coiled.Otherwise, the force exerted on the control section may not convey to the clip adequately during clipping.This could result in reduced performance, making it impossible to close the clip or detach it from the coil sheath after clipping.When forcing the clip against the tissue, do not try to rotate the clip.Doing so may tear tissue inside the body cavity, resulting in patient injury, such as perforation, bleeding, or mucous membrane damage.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 perforation, bleeding, or mucous membrane damage¿.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
Olympus was informed that during an unspecified procedure, the device detached and fell off into the patient; spring included.The item was successfully removed from the patient and another clip was used to successfully complete the procedure.There was no patient harm reported.
Additional Manufacturer Narrative
Additionally, the original equipment manufacturer (oem) is aware of the device issue and is currently being investigated.If additional information becomes available, this report will be supplemented accordingly.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Common Device Name: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8567545
• Report Number: 2951238-2019-00789
• Device Sequence Number: 11159771
• Product Code: PKL
• UDI-Device Identifier: 04953170385933
• UDI-Public: 04953170385933
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K123601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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-202UR
• Device Lot Number: 8YK 16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1