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

Model Number	HX-202UR
Medical Device Problem Codes	Break (1069); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The quick clip, hx-202ur has not been returned to the service center for evaluation for the reported event of misfire.Therefore, the exact cause of the reported event cannot be determined for the device.Upon receipt and evaluation of the device a supplemental report will be submitted.
Event or Problem Description
The service center received a report of a single use repositionable clip (hx-202ur), lot number 97k, that misfired inside a scope.It is unknown if the quick clip, hx-202ur, and the scope were inspected prior to the unspecified procedure.It was reported the clip misfired while inside the scope and the pieces fell into the patient.The physician retrieved the pieces and it was reported there was no patient injury.The scope was leak tested and passed.It was reported the scope will be returned to the service center to be verified and evaluation for any damage due to the reported event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation, complete lot number, manufacture date and additional information from the original equipment manufacturer (oem).The single use repositionable clip (hx-202ur), lot number 97k 29, was returned to the service center for the evaluation of misfire.The quick clip, was not returned in its original package.A visual inspection of the received condition of the device, noted evidence that clip had been deployed.The clip piece was not returned for evaluation.The insertion portion of the device was visually inspected and there were no dents, kinks or any other deformations noted.No damage was observed to the yellow tube joint.The handle slider was manipulated and the movement was observed to function consistently and smoothly as intended.Based upon the evaluation of the returned condition device, a root cause for the reported incident could not be determined, as the clip piece was not returned for evaluation.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 97k29, 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: 9771185
• Report Number: 8010047-2020-01558
• Device Sequence Number: 2815700
• Product Code: PKL
• UDI-Device Identifier: 04953170385933
• UDI-Public: 04953170385933
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 97K 29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1