MAUDE Adverse Event Report: Merit Maquiladora Mexico, S. DE R.L. DE C.V. CorVocet¿; INSTRUMENT, BIOPSY

Catalog Number	CORCA1615
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemoptysis (1887); Pneumothorax (2012)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A merit employee conducted a cer literature search (ortmans 2024) for the corvocet biopsy system.This study evaluated 240 patients.215 patients experienced no major complications.23 patients experienced pneumothorax requiring chest tube placement and hospitalization; 2 patients experienced events of hemoptysis requiring hospitalization with one patient requiring oxygen therapy and another patient requiring endotracheal intubation.Reference to the study: quant imaging med surg 2024;14(9):6830-6842.Doi: 10.21037/qims-23-500.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the product history and complaint database could not be performed since the lot number was not provided.The investigation is ongoing.If additional reportable information becomes available, it will be submitted in a supplemental report.

• Brand Name: CorVocet¿
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): Merit Maquiladora Mexico, S. DE R.L. DE C.V.; avenida sor juana ines; 19970 interior b, edificio 2; tijuana, baja california 22630 ; MX 22630
• Manufacturer (Section G): Merit Maquiladora Mexico, S. DE R.L. DE C.V.; avenida sor juana ines; 19970 interior b, edificio 2; tijuana, baja california 22630 ; MX 22630
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50934781
• Report Number: 3011642792-2026-00227
• Device Sequence Number: 10759326
• Product Code: KNW
• UDI-Device Identifier: 00884450373828
• UDI-Public: 00884450373828
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Device Catalogue Number: CORCA1615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown