MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP300S

Model Number 14047643515

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/19/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, leica biosystems was notified that the customer experienced suboptimal tissue processing on their asp300s tissue processor.As a result, two endometrial biopsies were undiagnosable.A re-biopsy was recommended; however as of (b)(6) 2018, no information has been provided to leica biosystems to confirm whether the re-biopsy has been performed.No re-biopsy sample has been received by the lab.A follow up report will be submitted if additional information is received.

Event Description

Following the leica manufacturer's investigation it was determined the incident was related to a pressure failure of the instrument.To date, a re-biopsy has not been performed.See manufacturer's report number 8010478-2018-00001 follow up #01 for additional information.

• Brand Name: LEICA ASP300S
• Type of Device: ASP300S
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 7278413
• MDR Text Key: 100397607
• Report Number: 1423337-2018-00002
• 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: 03/22/2018,01/19/2018

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: 14047643515
• 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: 03/22/2018
• Distributor Facility Aware Date: 01/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other