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

Catalog Number	A1615/B
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• Brand Name: Achieve®
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): Merit Maquiladora Mexico, S. DE R.L. DE C.V.; avenida sor juana ines de la c; 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 de la c; 19970 interior b, edificio 2; tijuana, 22630 ; MX 22630
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 meritt parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50781547
• Report Number: 3011642792-2026-00202
• Device Sequence Number: 16140944
• Product Code: KNW
• UDI-Device Identifier: 00884450443750
• UDI-Public: 00884450443750
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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
• Device Catalogue Number: A1615/B
• Device Lot Number: I3240987
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown