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	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, therefore, the exact cause of the reported event cannot be determined.
Event or Problem Description
The service center was informed that one clip that failed during a procedure.The quick clip pro was inspected prior to use and no abnormalities were observed.The physician was placing the clip during an esophago-gastro-duodenoscopy, in the area in which a 9 mm polyp was resected.The clip fell apart and that portion (spring)was not retrieved from the patient.It was reported another device was used to complete the procedure and there was no reported patient injury.
Additional Manufacturer Narrative
Nine new unopened repositionable clips (hx-202ur), lot 96k 20, were received to be evaluated for the reported complaint of ¿deploying on their own¿.The user¿s reported complaint was not confirmed.Four out of the nine repositionable clips were inspected and there were no issues to be identified with the devices.A visual inspection of the yellow joint below the handle area was observed to be in its proper location.It was observed that the distal end of the clips were opening and closing as intended when the slider was manipulated.It was also noted, there were no restrictions on the slider movement from the handle side.A test was performed on four out of the nine clips, where they were fired upon plain tissue paper, and all four clips securely clasped the tissue paper with no signs of misfiring.It was also observed there were no external damages on the insertion portion tube sheath, clip, slider, yellow joint and handle for each device.Based upon the evaluation, a determination was unable to be made on the cause of the reported event, as there were no damages or abnormalities observed with the devices.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem) along with the manufacture date.Please see updated sections: g4, g7, h2, h3, h4, h6, and h10.The original equipment manufacturer (oem) investigated samples of the single use repositionable clips (hx-202ur), from previous lots prior and up to mid lot 99k.Based on the oem¿s investigation, it was determined the root cause for the clips deploying on their own was a large clearance space between the clip arm and hook.The repositionable clip, hx-202ur, from lot 96k20, was manufactured prior to the implementation of the new specification.The oem has implemented modification of the size variance of the hook and 100% inspection of the manufacturing process.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 9484412
• Report Number: 8010047-2019-04384
• Device Sequence Number: 234083
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2020

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: 96K 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/20/2019; 02/19/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 12/30/2019; 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 68