MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC BENCHMARK ULTRA STAINER MODULE; SLIDE STAINER, AUTOMATED

Catalog Number 05342716001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Date 08/08/2016

Event Type  Injury  

Manufacturer Narrative

Through the course of the investigation, no instrument malfunction or leakage was identified.The benchmark ultra user guide provides instructions on how to properly dispose of waste to avoid injury.No additional details surrounding the operator's injury have been provided; it was noted that the customer has been going to physical therapy because of the injury sustained on her right arm and has also been to a neurologist.(b)(4).

Event Description

A customer in norway injured her right arm when disposing waste from the ventana benchmark ultra instrument.The customer had a swollen arm with pain.Because of the injury, the customer received a week's sick leave and was back at work after her sick leave.The customer has been going to physical therapy because of the injury sustained on her right arm and has also been to a neurologist.

• Brand Name: BENCHMARK ULTRA STAINER MODULE
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: stacie-ann creighton ; 1910 e innovation park dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 8631816
• MDR Text Key: 145779304
• Report Number: 2028492-2019-00008
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 05342716001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention