MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME EX BIOPSY SYSTEM

Model Number	HH8BEX
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mammotome ex probe is a sterile, single patient use instrument that may be used with imaging guidance, such as ultrasound, to excise a diagnostic sample from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.Device evaluation is anticipated, however devicor medical products, inc.Has not yet received the device for evaluation.Based on the fact that there was an unintended piece of the device left in the patient breast and pursuant to 21 cfr 803, we are submitting this medwatch report.
Event or Problem Description
Devicor medical products, inc.Received a report from affiliate, devicor medical (b)(4) ltd., stating, the equipment was operating normally, the capital and the probe were connected.During the procedure, when the user pressed the biopsy button, the plastic part of the specimen collection chamber was broken and got into the patient's breast.The user was able to identify the piece using ultrasound and remove this part at the next breast tissue biopsy.This has been documented in our system as record # (b)(4).
Additional Manufacturer Narrative
Devicor medical products, inc.Received the device for investigation.Visual inspection of the returned device has been completed and it was confirmed that the tip of the plastic component (ko tip) is missing from the metallic line (ko line).The ko tip is never introduced in the patient.The function of this tip is to expel the tissue inside the cutter to the collection chamber; the only way to introduce the tip inside the patient is if the tip was sheared off by the cutter during the translation or the tip was sheared off accidentally manually and unintentionally placed in the pathway of the cutter, passing through the needle.Funtional testing was conducted at the manufacturing site to attempt to duplicate the failure with no success.The manufacturing process was reviewed and no areas were identified that could shear the ko tip.Based upon the returned sample evaluation and manufacturing process review, no direct cause or root cause could be determined for the shearing of the ko tip.

• Brand Name: MAMMOTOME EX BIOPSY SYSTEM
• Common Device Name: MAMMOTOME EX BIOPSY SYSTEM
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8800033
• Report Number: 3008492462-2019-00034
• Device Sequence Number: 14088541
• Product Code: KNW
• UDI-Device Identifier: 10841911100956
• UDI-Public: (01)10841911100956(17)240321(10)F11911495D
• Combination Product (Y/N): N
• PMA/510(K) Number: K033700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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 Expiration Date: 03/21/2024
• Device Model Number: HH8BEX
• Device Catalogue Number: HH8BEX
• Device Lot Number: F11911495D
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention