MAUDE Adverse Event Report: LEICA BIOSYSTEMS RICHMOND CRYOSTAT; MICROTOME, CRYOSTAT

Lot Number 1510S-3

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2016

Event Type  malfunction  

Event Description

While cutting patient tissue the cryostat began "chunking out" or cutting too deeply and too quickly into the specimen, thereby leaving the tissue unreadable and not viable.The provider was immediately notified and the "troubleshooting" steps at the operator level were performed.These steps were deemed not helpful in rectifying the problem, again the provider was notified and leica, the manufacturer was notified.Leica arrived on site and substantiated, that indeed the machine was not performing correctly and was giving inconsistent results and began "troubleshooting" at the manufacturer level.After several failed attempts to correct the machine, it was determined that a new head was to be installed in the machine the next day and that a "loaner" machine would be sent overnight for the next business day.Unfortunately, during the machine malfunction, the patient's specimen was damaged and not able to be interpreted.This required additional tissue to be taken and sent for permanent section.Manufacturer response for cryostat, (brand not provided) (per site reporter): refer to description of event.

• Brand Name: CRYOSTAT
• Type of Device: MICROTOME, CRYOSTAT
• Manufacturer (Section D): LEICA BIOSYSTEMS RICHMOND; 5205 us highway 12; richmond IL 60071
• MDR Report Key: 6056770
• MDR Text Key: 58380255
• Report Number: 6056770
• Device Sequence Number: 1
• Product Code: IDL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1510S-3
• Other Device ID Number: 347302
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR