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

Model Number	HX-202UR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced device will not be returned for evaluation as the user facility discarded the device following the procedure.Therefore, the cause of the reported event cannot be confirmed.As a preventive measure, the instruction manual provides directions to "always have a spare instrument available." the instruction manual also states that to prevent clip malfunction, "never use excessive force to operate the instrument.This could damage the instrument." and "do not force the instrument if resistance to insertion is encountered." in addition, there are warnings and cautions that clip operation and closure is more compromised with an excessively angulated scope, firm tissue, or after the clip has been opened/closed more than 5 times.The instruction manual also has directions for pre-procedure inspection of the clip apparatus, and states that the use of the device is restricted to compatible olympus endoscopes, and to specific tissue types and sizes.
Event or Problem Description
The manufacturer was informed that during the middle of a colonoscopy with polypectomy procedure, the entire clip fell into the patient's colon.The clip was passed through a non-olympus scope and when the sheath was pulled back the entire clip fell off into the colon.The clip had not touched any tissue.The clip fell in an open position but they were able to snare the clip and the clip was removed intact using the scope.The lead rn stated there was not any restriction within the channel.There was minimal delay, and other clips were used without problems to complete the intended patient treatment as planned.The scope and clip were inspected prior to procedure per protocol without any abnormalities.There was no unexpected bleeding from the patient and there was no extra medical or surgical intervention as a result of the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of a device history record (dhr) review and update section h6.The device history record for the lot indicated no anomaly with the event-related inspection items below: process inspection sheet: clip movement.Clip engagement.Quality inspection sheet: general appearance of insertion portion.Opening width of the clip.Nonconforming product report.

• 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: 9124451
• Report Number: 8010047-2019-03394
• Device Sequence Number: 14068297
• Product Code: PKL
• UDI-Device Identifier: 04953170385933
• UDI-Public: 04953170385933
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 95K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 03/02/2020
• 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: SCOPE: FUJI EC760R V/L