MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP300; TISSUE PROCESSOR

Model Number 14047634101

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/14/2017

Event Type  Injury  

Event Description

On 29 june 2017 leica biosystems received a complaint that a customer experienced suboptimal tissue processing on their leica asp300.On (b)(6) 2017, a leica field support specialist was notified that as a result of the suboptimal tissue processing, five tissue blocks were undiagnosable.Leica biosystems has made attempts to obtain the patient identifier information but at this time the customer is not able to provide this information.Additionally, to date no confirmation of a rebiopsy has been provided to leica.If additional information is provided a follow up report will be submitted.

Event Description

Following the manufacturer's investigation, the incident was presumably user related due to a wrong application at the customer site.An instrument reagent bottle, used during the tissue processing, was filled with an incorrect reagent before processing, thus affecting the tissue.As per the initial report, the tissue was reported as undiagnosable but no confirmation has been provided that a rebiopsy was necessary or conducted.See manufacturer report number 8010478-2017-00006 for additional information.

• Brand Name: LEICA ASP300
• Type of Device: TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 6792296
• MDR Text Key: 82619727
• Report Number: 1423337-2017-00010
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2017,07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 14047634101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2017
• Distributor Facility Aware Date: 07/14/2017
• Event Location: Other
• Date Report to Manufacturer: 10/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other