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

Model Number MEP13

Device Problems Unsealed Device Packaging (1444); Shipping Damage or Problem (1570); Device Damaged Prior to Use (2284); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

Mep13 probes are sterile, single use devices, shipped in cartons of five.The carton is shipped in a larger shipper box that contains "air pillows" to fill any void.One mep13 probe from lot# f11704458d was received on march 28, 2017 and evaluated on may 17, 2017.Device was received in new condition.Package integrity was found to be compromised.The voc only indicated that the device and device carton were damaged.The extent of the damaged was not provided.The condition of the shipping box is unknown.This lot was 100% inspected on february 21st, 2017 and found to have no visual defects.Product was shipped to the customer on march 3, 2017 and delivered on march 6, 2017.The device carton as well as the shipper box were not returned for analysis thus preventing a determination of root cause.However, based on product knowledge, the reported event could be caused by: damage during shipping, carton being dropped or mishandled at user facility.The devicor medical product's, inc.'s quality system classifies the initial voice of the customer as a non-reportable malfunction.However, due to the discovery of the breached sterility, an additional reportability assessment was conducted for the additional failure mode observed within the investigation.The failure mode discovered during the investigation was determined to be a reportable malfunction due to the potential contamination and possibility for patient infection as a result of the sterility breach and pursuant to 21 cfr 803.Thus, we are submitting this medwatch report.

Event Description

The sales rep reported a damaged probe.The carton was damaged and one of the probes was unusable.Device is available for return.

• Brand Name: MAMMOTOME ELITE BIOPSY PROBE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juana ines de la cruz; #20152 4-b, parque industrial; tijuana, baja california 22440 ; MX 22440
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 6644752
• MDR Text Key: 77728517
• Report Number: 3008492462-2017-00039
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00841911100898
• UDI-Public: (01)00841911100898(17)210131(10)F11704458D
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: MEP13
• Device Catalogue Number: MEP13
• Device Lot Number: F11704458D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1