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

Model Number	INS-0372
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, patient was under sedation for a biopsy of a suspect nodule measuring 38 mm in the lung utilizing the ig4 system and associated instrumentation.Dr.(b)(6) started with the 19ga always- on tip tracked (aott) biopsy needle and got to the target with ease.After two passes, pathology saw atypical cells looking like non small cell but wanted more samples.Completed six more passes with the needle and then switched to the always-on tip tracked serrated forceps.Received one good sample and the patient started to bleed.The physician washed the area with epi, kept the scope in an additional 5 minutes to watch the bleeding.The bleeding slowed down and the patient was able to go home same day.

• Brand Name: ALWAYS-ON TIP TRACKED SERRATED FORCEPS
• Common Device Name: SERRATED FORCEPS
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.; 1908 innerbelt business center; st. louis MO 63114
• MDR Report Key: 7772916
• Report Number: 3007222345-2018-00003
• Device Sequence Number: 11110687
• Product Code: JAK
• UDI-Device Identifier: 00815686020576
• UDI-Public: 00815686020576
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2018
• Report Date (Section F): 08/09/2018

1 Device 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 Expiration Date: 10/19/2020
• Device Model Number: INS-0372
• Device Catalogue Number: INS-0371
• Device Lot Number: 03178171002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Date Report Sent to FDA: 08/09/2018