MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. PADLOCK CLIP DEFECT CLOSURE SYSTEM; DEFECT CLOSURE DEVICE

Model Number	C910001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of this complaint was returned to steris endoscopy for evaluation.Evaluation of the returned device found the linking cable was kinked and buckled, indicative of overly aggressive bending of the cable, and of excessive force applied upon deployment.The observed damage would cause the deployment issue described.Statements from the instructions for use include: "check to ensure that the scope is inserted completely into the scope mounting feature of the delivery housing and that the housing isn't expanded.Too tight of a fit can expand the scope mounting feature making the pushing mechanism sluggish and allow the padlock clip to get hung up on deployment, especially in retroflexion.Avoid bending the linking cable too aggressively or using a grasping/clamping device on the linking cable as it can create a "kink" and/or disable device function.Deploy padlock clip by using a firm and rapid thrust of the thumb actuator while holding the control handle body." the device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Steris endoscopy has offered in-service training to the user facility; however, the user facility has not responded.No further issues have been reported.
Event or Problem Description
The user facility reported incomplete deployment of a padlock clip defect closure device during a patient procedure, and the user utilized forceps to assist deployment.The clip was deployed successfully, the procedure was completed, and no harm to the patient or user was reported.

• Brand Name: PADLOCK CLIP DEFECT CLOSURE SYSTEM
• Common Device Name: DEFECT CLOSURE DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 10680065
• Report Number: 1528319-2020-00035
• Device Sequence Number: 3777367
• Product Code: PKL
• UDI-Device Identifier: 00816765013793
• UDI-Public: (01)00816765013793
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K180689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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 Expiration Date: 02/06/2022
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: 1902255
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1