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

Model Number	C913131
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon follow up with the user facility, the patient was reported to have a tortuous sigmoid colon as well as diverticula which may have contributed to the reported event.The device subject of this complaint has not been returned to steris endoscopy for evaluation.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.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 there is no gap on the open side where the scope and distal housing meet.See figure 3.Grasp the securing strap and stretch it across the "c" shaped opening and secure the securing strap onto the #2 securing strap mounting hook on the far side.Carefully apply lubricant liberally to the outside of the padlock clip housing." steris endoscopy has offered in-service training to the user facility; however, the facility has declined.No further issues have been reported.
Event or Problem Description
The user facility reported that the housing component of a padlock clip pro-select defect closure device became detached from the endoscope following use to close a defect in the cecum.The endoscope was re-inserted to attempt recovery of the component, and a perforation was observed in the sigmoid.The patient was sent to surgery to repair the perforation and retrieve the detached component.The patient is reported to be stable and recovering from surgery.

• Brand Name: PADLOCK CLIP PRO SELECT 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: 10692699
• Report Number: 1528319-2020-00036
• Device Sequence Number: 3185323
• Product Code: PKL
• UDI-Device Identifier: 00724995184254
• UDI-Public: (01)00724995184254
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: C913131
• Device Catalogue Number: C913131
• Device Lot Number: 2004542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1