MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH LEICA CM1950

Model Number 1491950C1US

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tissue Damage (2104)

Event Date 09/12/2019

Event Type  Injury  

Event Description

On 23 september 2019, leica biosystems received a complaint that a tissue sample was lost because the doctor was cutting without the blade in the leica cryostat instrument.No further information regarding a diagnosis or possible rebiopsy was provided.If additional information becomes available a follow up report will be submitted.

• Brand Name: LEICA CM1950
• Type of Device: LEICA CM1950
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 9221991
• MDR Text Key: 169730331
• Report Number: 1423337-2019-00011
• Device Sequence Number: 1
• Product Code: IDP
• 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
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1491950C1US
• 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: 10/22/2019
• Distributor Facility Aware Date: 09/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other