MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME REVOLVE ULTRASOUND PROBE; BIOPSY INSTRUMENT

Model Number	MHUS08
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mhus08 probes are sterile, single use devices, indicated to obtain samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.The device was returned to devicor for investigation.Breast tissue was found in the cup upon receipt.The probe initialized without issue, however, no tissue was obtained in 2 attempts.Lateral and axial vacuum lines were found to be pinched at the point where they attach to the probe.Several attempts to discover the failure point were made without success.Due to the discovery of breast tissue, this event was assessed against the result of the investigation.Following consultation with our medical director, due to the potential to cause or contribute to death or serious injury as a result of potential missed or lost tissue samples, pursuant to 21 cfr 803, this failure mode was determined to be a reportable malfunction.
Event or Problem Description
Devicor medical products, inc.Received a report from our affiliate, devicor medical korea, stating, "during a breast biopsy procedure 1.The samples were stuck in the need shaft and didn't come out.2.The customer completed the procedure with another new probe.No patient consequence." on september 10, 2019, mammotome became aware that breast tissue was unexpectedly found in the device during the failure investigation.This has been documented in our system as record # (b)(4).

• Brand Name: MAMMOTOME REVOLVE ULTRASOUND PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; 5th floor; cinncinati OH 45241
• MDR Report Key: 9145810
• Report Number: 3008492462-2019-00045
• Device Sequence Number: 16844620
• Product Code: KNW
• UDI-Device Identifier: 00841911100812
• UDI-Public: (01)00841911100812(17)211029(10)F11843489D
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2021
• Device Model Number: MHUS08
• Device Catalogue Number: MHUS08
• Device Lot Number: F11843489D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1