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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 Consequences Or Impact To Patient (2199)
Event Date 12/01/2016
Event Type  Malfunction  
Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report. The label matches the product returned. Our laboratory evaluation of the product said to be involved confirmed the report. During a visual inspection of the returned device, the head of the snare was damaged and outside the sheath at the distal end of the device. A functional test was performed on the device, the handle was manipulated multiple times and the snare head would advance and retract, but the distal tip of the snare head would not retract completely back into the sheath. When the snare head was in the advanced position and outside the sheath, the snare head appeared to be bent and misshaped. The sheath appears to be bunched up and kinked from the handle of the device to 2. 7 cm away from the distal tip of the handle. 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 state "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 use. Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection and functional test to ensure device integrity. A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment. Corrective actions: a review of the complaint history was conducted. The likelihood of occurrence is considered remote. 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

During an upper endoscopic procedure, the physician used a cook acusnare polypectomy snare. "during closing, the snare kinked [catheter kinked]. The physician was able to remove the device but they had to use another device to complete as kinked near the handle. No harm to patient and no additional procedures required due to this occurrence. ".

 
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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 Key6199470
MDR Text Key63197394
Report Number1037905-2016-00511
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK851958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 12/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Date12/01/2016
Device Age7 mo
Event Location Hospital
Date Manufacturer Received12/01/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/19/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/22/2016 Patient Sequence Number: 1
Treatment
ENDOSCOPE (UNKNOWN MAKE OR MODEL)
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