MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS ON TIP TRACKED FORCEPS

Model Number	INS-0372
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was an 88f with no pre-existing conditions.Metastatic lung cancer was originally suspected prior to the case.After the 5th bite with the serrated forceps, the patient began bleeding excessively, with blood eventually coming up the et tube.The physician was able to stop the bleeding by applying pressure with the scope and the patient was beginning to stop on her own.Pt was extubated the next day.No pneumothorax was noted.Pt.Stayed in the hospital 4 days and was set to be discharged on day 5.Physician stated that age and prescription of eliquis played a role in excessive bleeding.

• Brand Name: ALWAYS ON TIP TRACKED FORCEPS
• Common Device Name: ALWAYS ON TIP TRACKED FORCEPS
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• MDR Report Key: 11148822
• Report Number: 3007222345-2020-00015
• Device Sequence Number: 10920308
• Product Code: JAK
• UDI-Device Identifier: 00815686020576
• UDI-Public: 00815686020576
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: INS-0372
• Device Catalogue Number: INS-0372
• Device Lot Number: 04350200205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR