MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED FORCEPS, 1.8MM OD, SERRATED CUP; BIOPSY 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	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.H6: component code for "forceps" is not available.Selected "cutter/blade" and "jaw", as the forceps are meant to help hold tissue and sample tissue.
Event or Problem Description
The user facility contacted veran technical support (vsupport) for routine case support for a navigated bronchoscopy procedure.They reportedly registered with forceps (always-on tip tracked forceps, 1.8mm od, serrated cup).The physician started to sample with the forceps.After the second sample, he had to flush with cold saline because there was bleeding.The physician indicated that there was not an excessive amount of bleeding and he was able to control the bleeding with cold saline.The physician said that he was not going to have to perform any additional interventions.The navigated procedure was aborted because the physician did not want to take any more samples in fear of potentially causing excessive bleeding.There was no allegation of a malfunction of any veran devices.This report is being submitted due to the aborted procedure and bleeding that required medical intervention.

• Brand Name: ALWAYS-ON TIP TRACKED FORCEPS, 1.8MM OD, SERRATED CUP
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 18320656
• Report Number: 3007222345-2023-00081
• Device Sequence Number: 7129490
• Product Code: JAK
• UDI-Device Identifier: 00815686020576
• UDI-Public: 00815686020576
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown