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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US ENDOSCOPY GROUP, INC. PADLOCK CLIP; ENDOSCOPIC CLIP

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US ENDOSCOPY GROUP, INC. PADLOCK CLIP; ENDOSCOPIC CLIP Back to Search Results
Model Number C913131
Device Problems Positioning Failure (1158); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
The padlock clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.The device was not returned to us endoscopy for evaluation.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use state: carefully examine unit to verify that neither the contents nor the package has been damaged in shipment and if damage is evident, do not use this product and contact your local product specialist or customer service representative.Deploy padlock clip by rapidly pushing the thumb actuator while holding the handle body.In-service training was completed immediately following the event.There have been no further reports of partial deployment.
 
Event Description
The user facility reported that a padlock clip failed to fully deploy during procedural use.The device was removed from the patient with the tips of the clip component protruding from the delivery system housing.There was no report of harm to the patient or user and the procedure was completed with a second padlock clip device.
 
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Brand Name
PADLOCK CLIP
Type of Device
ENDOSCOPIC CLIP
Manufacturer (Section D)
US ENDOSCOPY GROUP, INC.
5976 heisley road
mentor OH 44060
Manufacturer (Section G)
US ENDOSCOPY GROUP, INC.
5976 heisley road
mentor OH 44060
Manufacturer Contact
coletta cohara
5976 heisley road
mentor, OH 44060
4403586251
MDR Report Key7652353
MDR Text Key113163215
Report Number1528319-2018-00018
Device Sequence Number1
Product Code PKL
UDI-Device Identifier00816765013809
UDI-Public(01)00816765013809
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 06/29/2018
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
Device Operator Physician
Device Expiration Date03/13/2021
Device Model NumberC913131
Device Catalogue NumberC913131
Device Lot Number1804311
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/05/2018
Initial Date FDA Received06/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2018
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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