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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
Catalog Number TRI-25M-P
Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Align (2522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: erbe electrosurgical generator, olympus visiglide 2 wire guide 0. 025", unknown reference part number. Investigation evaluation: an evaluation of the returned device confirmed the report of incorrect cutting wire orientation. During our laboratory analysis, the sphincterotome was advanced through a duodenoscope that was placed in a simulated biliary position. The duodenoscope has an accessory channel that is 4. 2 mm in diameter (olympus model number tjf-160v). The catheter exited the endoscope with the cutting wire facing 6 o'clock. The device was then bowed and the cutting wire was facing 6 o'clock (appropriate orientation is approximately 11:00 - 1:00 o'clock). The sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was 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 for the lot number said to be involved could not be reviewed because a lot number was not provided. 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 protector sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity. 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 user manually formed the sphincterotome tip, 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) and endoscopic sphincterotomy (est), the physician used a cook tri-tome pc protector sphincterotome. The physician inserted the sphincterotome into the endoscope with another manufacturer's wire guide and accessed the ampulla. The direction of the tip was not at the 11 o'clock direction [incorrect cutting wire orientation]. He could not access the ampulla and used a new one for cannulation. 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 NameTRI-TOME PC PROTECTOR
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
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key8601512
MDR Text Key150138631
Report Number1037905-2019-00249
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K901443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 04/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberTRI-25M-P
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
Was Device Evaluated by Manufacturer? Yes
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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