MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMTOME REVOLVE ULTRASOUND PROBE (10G); BIOPSY INSTRUMENT

Model Number	MHUS10
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mhus10 probes are sterile, single use devices, indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.One mhus10 probe from lot # f11811410d was received in fair condition.Use in a procedure was evident on the probe.The was probe connected to a holster for functional evaluation.Using chicken breast as a medium, the device was unable to obtain samples.Further visual inspection found breast tissue clogged in the device cutter.Once the cutter was cleared, the device obtained samples as designed.The customer holster was not returned for evaluation.Based on product knowledge, the reported event could be caused by a lack of vacuum.Without a customer holster, a root cause cannot be confirmed.The initial voice of the customer on (b)(6) 2018 was deemed not reportable as no patient consequence was noted.However, due to the discovery of the tissue, on 8/20/2018 during the device evaluation, this event was reassessed for reportability based on the findings 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
Report received from affiliate, devicor medical (b)(4) stating, "once probe was inserted in the patient, sample cup did not rotate, and sampling button was not functioning.New probe was attached to holster, it functioned properly to complete the procedure." this has been documented in our complaint system as record # (b)(4).

• Brand Name: MAMMTOME REVOLVE ULTRASOUND PROBE (10G)
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 7850155
• Report Number: 3008492462-2018-00067
• Device Sequence Number: 16563724
• Product Code: KNW
• UDI-Device Identifier: 00841911100829
• UDI-Public: (01)00841911100829(17)210320(10)F11811410D
• Combination Product (Y/N): N
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/08/2018

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: 03/20/2021
• Device Model Number: MHUS10
• Device Catalogue Number: MHUS10
• Device Lot Number: F11811410D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1