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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number ASDB-15-015-S
Device Problem Retraction Problem (1536)
Patient Problem No Patient Involvement (2645)
Event Date 02/21/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. During a visual inspection of the returned snare there was a kink in the sheath near the distal end of the handle. The kink was located from 2. 1 cm to 3. 2 cm from the handle. A second kink was observed near the distal tip. The kink was located at 6. 8 cm from the distal tip of the device. During a functional test with the device outside of an endoscope the snare head advanced and retracted as intended. The device was then placed down a 3830 tl pentax colonoscope (2. 8 mm channel). The scope was placed in a straight position. When the handle of the device was manipulated the snare head would advance and retract without resistance as intended. The colonoscope was then placed in a curved position to demonstrate a worst case scenario. The handle of the device was manipulated and resistance was encountered with advancing and retracting the snare head. It was observed that when retracting the snare head with the colonoscope in a curved position that the sheath near the handle would begin to bunch up. It is most likely that the resistance felt by the user was due to the kink near the handle. An additional functional test was performed outside the endoscope. The continuity from the electrical pin to the snare head was tested with an ohm meter and passed. The active cord would connect and remained securely connected without any issues. The device was connected to a valley lab generator and power was applied to cut simulated tissue. The snare cut the simulated tissue as intended. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting. Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis. This limits our ability to conclusively determine a cause. The instructions for use states: "if the package is opened or damaged when received, do not use. Visually inspect with particular attention to kinds, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use. " the instructions for use directs the user to: "fully retract and extend snare to confirm smooth operation of device. " the instructions for use directs the user to: "advance device, in small increments, until endoscopically viewed exiting endoscope. " damage to the product can occur if the device experiences excessive pressure during handle/preparation. Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
 
Event Description
In preparation for a procedure, the user selected a cook acusnare polypectomy snare. The catheter is compressing/shrinking close to the handle when closing the snare and applying pressure before resecting the polyp. According to the customer the sheath of the snare is too soft. There was no reportable at this time. Additional information was received on 02/27/2018: if the forceps [snare]/handle is pulled, the catheter inverts (after about 2 cm) together. The catheter is folded/compressed by the pressure, about 2 cm after the handle. There was no reportable information at this time. The device was evaluated on 03/15/2018. It was determined that the snare was difficult to retract.
 
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Brand NameACUSNARE POLYPECTOMY SNARE
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key7407666
MDR Text Key105379015
Report Number1037905-2018-00139
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K851958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASDB-15-015-S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/21/2018
Device Age1 MO
Event Location Hospital
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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