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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 Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Gastrointestinal Hemorrhage (4476)
Event Date 06/14/2021
Event Type  Injury  
Manufacturer Narrative
Pma/510(k) # k172665. The investigation is on-going. A follow-up emdr will be provided,.
 
Event Description
During an endoscopic sphincterotomy (est) procedure, the physician used a cook tri-tome pc protector. When the physician cut the vater's papilla, bleeding occurred. He checked the cutting wire and found it looked thinner than before. [the physician stated that] it could cause increasing of heat conductivity. The boundaries of heat insulation coating are unclear as well. The user managed to stop bleeding and placed the tube stent to complete the procedure. A section of the device did not remain inside the patient¿s body. The procedure was finished with another manufacturers' est knife on a different day due to this occurrence. According to the initial reporter, the patient experienced bleeding and the physician stopped the bleeding.
 
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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
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key12150740
MDR Text Key260998266
Report Number1037905-2021-00304
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberTRI-25M-P
Device Lot NumberW4386909
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2020
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: 07/12/2021 Patient Sequence Number: 1
Treatment
OLYMPUS ENDOSCOPE / MODEL UNKNOWN; VIO ELECTROSURGICAL GENERATOR
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