MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED FORCEPS, 1.8MM OD, SERRATED CUP; SERRATED FORCEPS

Model Number	INS-0372
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is expected to be returned to veran for evaluation.The device has not yet been received.This report will be supplemented accordingly, once the investigation is complete, or if additional information is received.H6: component code for "cover" was used, since a component code for "sheath" is not available.
Event or Problem Description
After the intended procedure was completed, the physician noticed the ins-0372 (always-on tip tracked serrated forceps) sheath had ridges on it.The doctor said the ridges caused damage to the working channel of their scope.The procedure was successfully completed using the ins-0372 (subject device) and ins-5300 (always-on tip tracked triple needle brush) to obtain tissue samples.There was no patient or user injury reported due to this issue.Additional information has been requested from the user facility, but has not yet been received.

• Brand Name: ALWAYS-ON TIP TRACKED FORCEPS, 1.8MM OD, SERRATED CUP
• Common Device Name: SERRATED FORCEPS
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis 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
• MDR Report Key: 17147605
• Report Number: 3007222345-2023-00029
• Device Sequence Number: 5578101
• Product Code: JAK
• UDI-Device Identifier: 00815686020576
• UDI-Public: 00815686020576
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2025
• Device Model Number: INS-0372
• Device Catalogue Number: INS-0372
• Device Lot Number: 05456220113
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INS-5300 ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH.
• Patient Sex: Unknown