MAUDE Adverse Event Report: US ENDOSCOPY PADLOCK CLIP EFTR DEVICE

Model Number	00713229
Medical Device Problem Codes	Use of Device Problem (1670); Activation Problem (4042)
Health Effect - Clinical Codes	Bowel Burn (1756); Pain (1994)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris representatives were present during the time of the reported event and stated that torque and force were needed to navigate to the procedure area.The padlock clip eftr device subject of the reported event was returned for evaluation which found black residue within the device housing.There were no kinks or other damage noted.Further evaluation found that the snare loop capable of deployment when the housing opening was properly cleared.Steris attributed the black residue to the application of cautery while the snare loop was obstructed within the housing.The instructions for use (ifu 12943323) gives the user the following information: "do not articulate the endoscope abruptly; this could cause patient harm such as mucosal injury.Do not use this device with side viewing endoscopes because visualization is inhibited.Do not use this device in the upper gi system because it is only designed for the lower gi and may cause mucosal injury to patient if used incorrectly.Do not continue to squeeze the thumb ring and the spool if the device malfunctions and there is no clip deployment or tissue approximation.Carefully remove device from patient and return entire device to steris endoscopy and use a second device.If snare does not function properly, another procedure to remove the lesion may be necessary such as a snare polypectomy.It is not recommended to use another padlock clip eftr¿ device due to the unknown risk of placing another clip on top of the initial clip.Do not use if the device is damaged or if the sterile barrier has been compromised.This could result in patient injury or device failure.If damage is evident (such as bent or kinked linking cable, or cracked, broken, protruding, or missing parts of the housing or handle), do not use this product.Save the device and packaging and contact your local steris endoscopy product specialist." steris performed in-service training on the proper use and operation for the padlock clip.The device history record was reviewed and confirmed the lot subject of the reported event was manufactured to specifications; no abnormalities were noted.A review of complaints confirmed the event to be isolated for the subject lot.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure which included use of the padlock clip eftr device, the tissue did not resect as intended.The doctor reported there was no serious injury to the patient, however there was a mild thermal injury on the opposite wall and clips were prophylactically placed.The procedure was successfully completed with a replacement snare.
Additional Manufacturer Narrative
This report is being supplemented to provide correction in d2 for the product code and additional information in h6 for the health effect clinical code and health effect impact code.Additionally, this report is being supplemented to provide additional information regarding our investigation in h11: the application of cautery was not the cause of the "snare loop obstructed within the housing." through our investigation, it was determined that the cause was due to the user squeezing the thumb ring and spool to deploy the clip and snare too quickly.As the user did not use a steady and controlled motion to close the handle, this caused the snare to not deploy as intended.The user applied electrosurgical power to cut the lesion after deployment; however, the snare was caught on the housing resulting in the reported black residue.The instructions for use includes instructions to properly deploy the clip and snare: "deploy clip and snare by squeezing thumb ring and spool in one steady controlled motion until spool approaches thumb ring, and the snare is tightly closed around the tissue (see figure 8)." "step 1: deploy clip and snare in one steady controlled motion." "one steady controlled motion is necessary to avoid losing placement of snare over the lesion." user facility personnel were counseled on the importance of using a steady and controlled motion when deploying the clip and snare.

• Brand Name: PADLOCK CLIP EFTR DEVICE
• Common Device Name: PADLOCK CLIP EFTR DEVICE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20584682
• Report Number: 1528319-2024-00095
• Device Sequence Number: 12940137
• Product Code: FDI
• UDI-Device Identifier: 00724995226732
• UDI-Public: (01)00724995226732(11)240925(17)250730(10)11083791
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K240274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2024

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: 07/30/2025
• Device Model Number: 00713229
• Device Catalogue Number: 00713229
• Device Lot Number: (10)11083791
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 04/17/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown