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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY HUIBREGTSE NEEDLE KNIFE PAPILLOTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK ENDOSCOPY HUIBREGTSE NEEDLE KNIFE PAPILLOTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number HPC-2
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/13/2021
Event Type  Injury  
Event Description
During an endoscopic procedure, the physician used a cook huibregtse needle knife papillotome. It was reported that during the first cut, the cutting tip of the device came off and got stuck in the papilla. A section of the device did not remain inside the patient¿s body. Biopsy forceps were used to remove the broken part from the patient. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation. The report could not be confirmed. 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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation. A definitive cause for the reported observation could not be determined. Needle knife breakage near the distal end can occur if the device is used with excessive cautery settings. The instructions for use direct the user: "before using this device, follow recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode. Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure. " needle knife breakage near the distal end can occur if the needle makes contact with the distal end of the endoscope during a cautery application. The instructions for use caution the user: "when applying current, ensure needle knife is completely out of endoscope. Contact of needle knife with endoscope may cause grounding, which can result in patient injury, operator injury, a broken needle knife, and/or damage to endoscope. " needle knife breakage near the distal end can also occur if the product experiences limited movement of the needle knife during electrocautery application. The instructions for use state: "caution: it is essential to move needle knife while applying current. " maintaining the needle knife in one position can result in breakage of the needle knife. Prior to distribution, all huibregtse needle knife papillotomes are subjected to a visual inspection and functional test to ensure device integrity. 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.
 
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Brand NameHUIBREGTSE NEEDLE KNIFE PAPILLOTOME
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key13225263
MDR Text Key283600572
Report Number1037905-2022-00012
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K972674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberHPC-2
Device Lot NumberW4481564
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2021
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: 01/11/2022 Patient Sequence Number: 1
Treatment
ENDOSCOPE, UNKNOWN MAKE OR MODEL
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