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

Model Number	HH11BEX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Laceration(s) (1946); Injury (2348)
Date of Event	05/30/2019
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 obtain tissue samples from the breast for diagnostic analysis of breast abnormalities.The device was returned to devicor medical products, inc.For evaluation.The device was received in two pieces.User reported that the device was removed from the physician's finger by cutting the probe with a cast saw.Our evaluation noted pieces of glove found twisted around the cutter.The probe is cut through the tissue collection area which cut through the cutter, lower lumen, and the probe housing.The cutter is forward approximately 1.6 inches from the sampling area but not visible in the aperture.Multiple attempts were made to get additional incident information from the user facility without success.They report that the physician is doing well.No information provided regarding medical intervention required.Without further incident details we are not able to determine root cause for the reported incident.Instructions for use state: "sterile forceps may be used to aid in removing the specimen from the knockout tube or distal end of the specimen collection chamber".And warn: "do not place any instruments or objects in the specimen collection chamber when the cutter is moving".
Event or Problem Description
Devicor medical products, inc.Received a report from a user facility stating, "during the procedure the physician had her finger stuck in the ex probe between the cutter and the end of the collection chamber.She was unable to remove her finger, the cutter was advanced forward and lodged so her finger could not be removed.When it jammed they had an error on the device so they shut it off and removed the probe from the breast." the user contacted devicor for information on how to remove the probe from the physician's finger.The user was instructed to remove the probe from the holster and advised to seek assistance with removal of the probe from the physician's finger in the emergency department.The probe was removed from the physician's finger in the emergency room.This has been documented in our systems as record # (b)(4).

• Brand Name: MAMMOTOME EX BIOPSY SYSTEM
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8741337
• Report Number: 3008492462-2019-00029
• Device Sequence Number: 2637751
• Product Code: KNW
• UDI-Device Identifier: 10841911100949
• UDI-Public: (01)10841911100949(17)240221(10)F11908410D
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K033700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 02/21/2024
• Device Model Number: HH11BEX
• Device Catalogue Number: HH11BEX
• Device Lot Number: F11908410D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/27/2019
• 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