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

Device Problem Insufficient Information (3190)

Patient Problem Fistula (1862)

Event Type  malfunction  

Manufacturer Narrative

Steris endoscopy contacted the user facility for additional information regarding the reported event; however, at this time we have not received a response.The device subject of this complaint was not returned to steris endoscopy for evaluation.The instructions for use include the following statements: "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." a complaint review indicates this to be an isolated event.A follow-up mdr will be submitted should additional information become available.

Event Description

The user facility reported that the clip component of a padlock clip defect closure device was found partially dislodged and embedded causing formation of a gastrogastric fistula behind the clip.The patient medical history includes gastric bypass surgery performed at another facility.The patient condition which led to treatment with a clip and facility which applied the clip are unknown.

Manufacturer Narrative

Through follow-up with the user facility, steris endoscopy learned that the patient arrived at the user facility reporting symptoms of pain and vomiting.After examination, the partially dislodged and embedded clip was identified.The clip had previously been placed at a different hospital.The patient condition which led to treatment with a clip is unknown.The patient left the user facility without further treatment.

• 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
• MDR Report Key: 12180855
• MDR Text Key: 261946990
• Report Number: 1528319-2021-00028
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1