MAUDE Adverse Event Report: INRAD INAD; INSTRUMENT, BIOPSY

Model Number 681014

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/01/2021

Event Type  malfunction  

Event Description

Three small metal pieces were left in the breast after using an inrad biopsy device, inrad 14gx10cm-lot #62101001- ref# (b)(4); hologic professional q shape clip- lot#51612- ref#(b)(4); bd eclipse needle 25g x 1 1/2 - lot#1002329- ref# (b)(4).

• Brand Name: INAD
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): INRAD; 4375 donkers ct se; grand rapids MI 49512
• MDR Report Key: 12696869
• MDR Text Key: 278357980
• Report Number: 12696869
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 681014
• Device Lot Number: 62101001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other