MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INVIVO; DS BREAST COIL

Model Number	DS BREAST COIL 7CH 1.5T
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that due to the insufficient medial compression plate in the mri, a large defect in the breast occurred during a vacuum biopsy.There is no indication of a coil or system malfunction.
Additional Manufacturer Narrative
Philips has started an investigation, a follow up will be submitted once completed.
Additional Manufacturer Narrative
Philips conducted a corrective action and preventive action (capa) of which the following is the summary: the investigation has showed that there was no product malfunction.The investigation showed that the customer failed to comply with the instructions for use (ifu) in the following way: as per instructions the usage is as follows: ifu 4535-303-07841, page no.4 clearly states that ¿before the intervention is performed, a confirmation scan should be acquired with the sleeve (and possibly stylet) inserted to ensure that the needle is positioned as desired.Incorporate the effects of needle throw into the risk evaluation.¿ it was found to be conducted instead : the operator / physician had performed the vacuum assisted biopsy without considering the manufacturer¿s ifu, which resulted in ¿less compression in medial plates caused spatial movement of the target lesion consequently missing the target lesion due to which physician had to target 12 biopsies lead to 5cm cut on the medial side of the breast.¿ the patient required a corrective procedure and has since recovered.

• Brand Name: INVIVO
• Common Device Name: DS BREAST COIL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 19292436
• Report Number: 1056069-2024-00001
• Device Sequence Number: 7142726
• Product Code: MOS
• UDI-Device Identifier: 00884838085541
• UDI-Public: 00884838085541
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: DS BREAST COIL 7CH 1.5T
• Device Catalogue Number: 459800766681
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female