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

Model Number	HX-202UR
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip and handle were not returned to the service center for evaluation.The exact cause of the reported event cannot be determined at this time.As a preventive measure, the instruction manual states that to avoid patient injury, ¿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.¿.
Event or Problem Description
The service center was informed that during an unspecified procedure, a third clip failed to deploy and when retrieving the clip it caused a tear to the patient¿s mucosa, with bleeding.The bleeding was controlled with an unknown device.It was reported that the end user had experienced deployment issues with two clips prior to the incident and these clips were not used on the patient.The intended procedure was completed with a competitor¿s device.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the device evaluation results.The service center received 1 used and 17 brand new and sealed hx-202ur quick clips (lot#91k) for evaluation.A visual inspection was performed on the received device on the 1 used quick clip and noted evidence of the clip being deployed.The clip was noted to be clip is in a closed position which is the proper way to use the device.The insertion portion was checked and there was no external damages.There is evidence of foreign material on the device.The handle was manipulated and the movement is consistent and smooth.In addition, a inspection was performed on 5 of the 17 brand new quick clips were opened to test the functions and found no issue with device.The handle was manipulated and observed the clip being deployed properly with no problem.There is no external damages to the insertion portion, handle, or the yellow tube joint.Based on the evaluation, the user¿s complaint could not be confirmed.As the device shows evidence of the device being deployed.The brand new quick clips had no issue and operate normal with no signs of abnormalities.This event has been reported by the importer on mdr # 2951238 - 2019 - 01129.

• 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: 9124180
• Report Number: 8010047-2019-03393
• Device Sequence Number: 14102683
• Product Code: PKL
• UDI-Device Identifier: 04953170385933
• UDI-Public: 04953170385933
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 91K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other