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

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.

• 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: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12150740
• MDR Text Key: 260998266
• Report Number: 1037905-2021-00304
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: TRI-25M-P
• Device Lot Number: W4386909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• 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