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

Model Number C910001

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 08/07/2022

Event Type  malfunction  

Manufacturer Narrative

Steris endoscopy contacted the user facility for additional information regarding the reported event.The physician described the event as a user error, as the user had difficulty positioning the endoscope with the padlock device in the duodenum and had also suctioned too much tissue into the padlock device prior to deployment of the clip.The physician stated the padlock device has worked as intended, with no report of device malfunction.Surgical intervention was required to repair the duodenal lumen.The event occurred on (b)(6) 2022.Steris was notified of the event on september 6, 2022.After multiple attempts to contact the user facility for additional information, steris endoscopy was informed on (b)(6) 2022, that the patient had multiple comorbidities and was deceased.The user facility provided no further information concerning the patient comorbidities and provided no information which associates the cause of death with the duodenal procedure or the intervention.The device subject of this complaint was not returned to steris endoscopy for evaluation, and the lot number was not provided.The instructions for use include the following statements: "when using suction to pull target tissue into the cap, there is a risk of capturing tissue/organs outside of the lumen and adjacent to the target treatment area.Use of a grasping device is recommended to acquire the target tissue and minimize the risk of capturing tissue/ organs adjacent to the treatment area." a follow up report will be submitted if additional information becomes available.

Event Description

The user facility reported that during a procedure which included use of the padlock clip defect closure system for treatment of a duodenal ulcer, the physician inadvertently deployed the clip in a manner which closed the duodenal lumen.

Manufacturer Narrative

Steris endoscopy has made several attempts to obtain additional information regarding the reported event.However, the user facility is not providing any additional information.No additional issues have been reported.

• Brand Name: PADLOCK CLIP DEFECT CLOSURE SYSTEM
• Type of Device: DEFECT CLOSURE DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 15550390
• MDR Text Key: 301250512
• Report Number: 1528319-2022-00050
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00724995184247
• UDI-Public: 00724995184247
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death