MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH ASP6025; ASP6025 TISSUE PROCESSOR

Model Number 14049543268

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456)

Patient Problems Tissue Damage (2104); Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the customer experienced suboptimal tissue processing.On (b)(6) 2018, leica biosystems was notified one case was undiagnosable and a re-biopsy was recommended, as a result of this suboptimal tissue processing.Minimal patient identifier information was provided by the customer and is found within this report.If additional information is obtained a follow up report will be submitted.

Event Description

Following the leica biosystems manufacturer's investigation, it was determined there was no failure of the instrument which would have led to undiagnosable tissue.Confirmation as to whether the re-biopsy was performed, has not been provided to leica.See manufacturer's report number 8010478-2018-00003 follow up #01 and #02 for additional information.

• Brand Name: ASP6025
• Type of Device: ASP6025 TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 7631458
• MDR Text Key: 112153121
• Report Number: 1423337-2018-00007
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/20/2018,05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 14049543268
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2018
• Distributor Facility Aware Date: 05/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR