MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP300S; TISSUE PROCESSOR

Catalog Number 14047643057

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Date 12/12/2013

Event Type  Injury  

Event Description

On (b)(6) 2014, leica biosystems received info from the customer that one patient sample needed to be re-biopsied.

Manufacturer Narrative

The unit has been evaluated ty a leica application specialist.The investigation revealed the following" the root cause is determined to be user error related.The customer had interchanged the reagents, because this event was a sudden deterioration and not a gradual process.According the customer the last time of changing the reagents was the day before the event occurred.After the event the reagents were changed and the customer conducted a new processing run which confirmed the proper functioning of the unit.A customer facing letter will be sent to the customer with the reference in future to follow the recommendation in the customer letter regarding the reagent handling.

• Brand Name: LEICA ASP300S
• Type of Device: TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger str. 17-19; nussloch 6922 6; GM 69226
• Manufacturer Contact: robert gropp ; heidelberger str. 17-19; nussloch 69226 ; GM 69226 ; 224143345
• MDR Report Key: 3809802
• MDR Text Key: 4524275
• Report Number: 8010478-2014-00005
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14047643057
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other