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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY TRI-TOME PC PROTECTOR; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK ENDOSCOPY TRI-TOME PC PROTECTOR; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number G49197
Device Problems Use of Device Problem (1670); Failure to Align (2522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical product: olympus visiglide 0.025 wire guide.Investigation evaluation: an evaluation of the returned device could not confirm the report of incorrect orientation.The device could not be tested functionally due to the broken cutting wire.The sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was not observed at the distal end.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.The device history record contains a nonconformance that could potentially be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.Investigation conclusion: responses to additional questions indicated that the distal end of the device was formed manually.The instructions for use advise the user: "do not apply manual pressure to tip or cutting wire of sphincterotome to influence orientation, as this may result in damage to device." this is the most likely cause for the reported observation.Prior to distribution, all tri-tome pc protectors 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: 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.Additional comments regarding this report: based on the information provided that the distal end of the device was formed manually, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
 
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook tri-tome pc protector.When they tried to do endoscopic sphincterotomy (est), the physician recognized that the orientation was wrong.The way [sic] of the tip of the catheter was almost at 2 o'clock.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand Name
TRI-TOME PC PROTECTOR
Type of Device
KNS, 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
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key8788947
MDR Text Key150978598
Report Number1037905-2019-00392
Device Sequence Number1
Product Code KNS
UDI-Device Identifier00827002491977
UDI-Public(01)00827002491977(17)211009(10)W4129157
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
K901443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 06/20/2019
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 Health Professional
Device Expiration Date10/09/2021
Device Model NumberG49197
Device Catalogue NumberTRI-25M-P
Device Lot NumberW4129157
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/20/2019
Initial Date FDA Received07/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
OLYMPUS TJF-240 ENDOSCOPE
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