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); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the service center for evaluation as it has been reported it has been discarded.Therefore, the exact cause of the reported event cannot be determined.
Event or Problem Description
The service center received a correspondence from alberta health canada, report ahs mdip #1220, that a single use repositionable clip fired open, would not close and fell apart into three pieces.The scope and clip were inspected prior to the procedure and no anomalies were observed.The scope used in the procedure was an olympus pcf h190dl.The reported incident occurred when the physician was using the clip, hx-202ur, lot number 96k, for a post polypectomy.The items were retrieved from the patient using biopsy forceps and discarded as it was reported the items were in contact with biohazard materials.The device will not be returned to the service center for evaluation as the items were discarded by the user facility.It was reported the patient did not have any apparent injury.The scope was inspected after the procedure and no abnormal observations were noted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem).Please see updated sections: d10, g4, g7, h2, h3, 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 96k, 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: 9701943
• Report Number: 8010047-2020-01313
• Device Sequence Number: 1681212
• Product Code: PKL
• UDI-Device Identifier: 04953170345203
• UDI-Public: 04953170345203
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS PCF H190DLS/N (B)(6)