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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. LARIAT SNARE; POLYPECTOMY SNARE

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UNITED STATES ENDOSCOPY GROUP, INC. LARIAT SNARE; POLYPECTOMY SNARE Back to Search Results
Model Number 00711119
Device Problem Entrapment of Device (1212)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2019
Event Type  malfunction  
Manufacturer Narrative
The user reported the snare had been actuated with force causing the catheter to buckle near the handle, and reported no visible cautery effect.Actuation with excessive force can damage and disable the device, preventing retraction of the snare loop with electrocautery and removal from the tissue.The handle and catheter portions of the lariat snare subject of the reported event were returned to us endoscopy for evaluation.Examination of the returned portions found a significant buckle of the catheter, consistent with the user report of buckling following the application of excessive force.The drive cable and snare loop portions were not returned, consequently the electrocautery function could not be evaluated.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.The instructions for use include the following statements: the following conditions may not allow the lariat snare device to function properly: advancing the handle to the open position with too much speed or force, attempting to actuate the device in an extremely coiled position and/or actuating the device when the handle is at an acute angle in relation to the sheath.To prevent inadvertent injury to the patient, avoid forcefully closing the device without adequate electrocoagulation.A us endoscopy representative has provided in-service training including instruction on use of snare without excessive force.No additional issues have been reported.
 
Event Description
The user facility reported that, during piecemeal resection of a 7-8 cm polyp in the colon, the snare loop of a lariat snare became entrapped in the polyp tissue.The user attempted to disengage the snare from the polyp without success and an additional procedure was required to remove the snare and complete the polypectomy.The patient is reported to be well.
 
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Brand Name
LARIAT SNARE
Type of Device
POLYPECTOMY SNARE
Manufacturer (Section D)
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley rd
mentor OH 44060
Manufacturer (Section G)
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley rd
mentor OH 44060
Manufacturer Contact
coletta cohara
5976 heisley rd
mentor, OH 44060
4403586251
MDR Report Key8825832
MDR Text Key156588533
Report Number1528319-2019-00029
Device Sequence Number1
Product Code FDI
UDI-Device Identifier00816765012550
UDI-Public(01)00816765012550
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151197
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Physician
Type of Report Initial
Report Date 07/25/2019
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
Device Operator Health Professional
Device Expiration Date01/02/2022
Device Model Number00711119
Device Catalogue Number00711119
Device Lot Number1820674
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/25/2019
Initial Date FDA Received07/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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