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

Model Number MEP10

Device Problems Use of Device Problem (1670); Missing Value Reason (3192); Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

The medtech referenced in this event contacted the manufacturer's sales rep and reported that she had injured herself during use of a mammotome elite biopsy system and that for any further details, to contact her lawyer.As a result, legal counsel for both the medtech/hospital, and the manufacturer have been communicating; however, details of the incident are still unfolding and not yet confirmed at this time.Due to the report of a serious injury occurrence, however, pursuant to 21 cfr 803, we are submitting this medwatch report.A follow -up report will be submitted when more details are available.Product not available.

Event Description

The sales rep reported that medtech was injured during set-up or completion of a biopsy procedure with a mammotome elite biopsy probe (mep13).Specific details are not known, but injury is indicated as being ankle or tendon.Investigation is still in progress.

Manufacturer Narrative

The information below was provided through a legal representative and notification stating the following.On february 2, 2017, the ultrasound technician prepared the product for use as she had been instructed by leica.Initially, she removed the probe from the probe housing, which was placed on a tray table.She then snapped the probe into the holster, removed the needle guard and placed the holster and probe back onto the open probe housing.Having prepared the product exactly as instructed by the leica representatives and while turning toward the ultrasound machine monitor, the holster and probe rolled off the table and speared her ankle.As the probe trocar penetrated her achilles tendon, the motor turned on by itself, causing the inner cutter to rotate at high speed.As a result, the product took a tissue sample of her achilles tendon.Technician was soon thereafter examined and treated at the emergency department.A mri was performed on (b)(6) 2017.The impression of the radiologist was that the technician suffered a high-grade partial tear of the distal achilles tendon, with approximately 80% of the tendon involved.Technician started physical therapy on (b)(6) 2017.Date of event has been updated to revise the date of event from (b)(6) 2017.Model #/lot # has been updated to revise the model # and catalog # from mep13 to mep10.Type of report has been updated to change type of report to follow-up #1.If follow-up, what type? has been updated to indicate follow-up type as additional information.(b)(4).

Event Description

The sales rep reported that medtech was injured during set-up or completion of a biopsy procedure with a mammotome elite biopsy probe (mep13).Specific details are not known, but injury is indicated as bing ankle or tendon.Investigation is still in progress.

• Brand Name: MAMMOTOME ELITE BIOPSY SYSTEM
• 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 ; 5138649178
• MDR Report Key: 6417352
• MDR Text Key: 70340491
• Report Number: 3008492462-2017-00012
• Device Sequence Number: 1
• Product Code: KNW
• 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,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MEP10
• Device Catalogue Number: MEP10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other