MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR,

Model Number PELORIS

Device Problems Device Maintenance Issue (1379); Appropriate Term/Code Not Available (3191)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 12/27/2016

Event Type  Injury  

Event Description

Leica biosystems received a complaint regarding sub-optimal tissue processing.On (b)(6) 2016, leica biosystems received the following information from the laboratory "there were two skin biopsies of suspected malignancies that were unreadable.They could not be re-biopsied since the original biopsy was the entire lesion.We had to sign the cases out with a disclaimer regarding suboptimal tissue processing.We could not make a definitive diagnosis in these 2 cases." patient information was not provided to leica biosystems, to date.Investigation of this complaint by leica biosystems is in progress and if additional information becomes available a follow up report will be submitted.

Event Description

The investigation by leica biosystems concluded that the processing reagent bottle concentration settings had been reset to the manufacturer default settings when a failed hard disk drive (hdd) was replaced by a leica field service engineer.The complainant's customized reagent bottle concentration settings specific to their processing protocol were not transferred over to the new hdd after the replacement was performed and thus led to the sub-optimal tissue processing.Information as to whether medical intervention was required to preclude permanent impairment of a body function or permanent damage to a body structure; and an identifier, gender and age or date of birth for each of the two (2) cases for which a definitive diagnosis could not be made, has been sought.If additional information becomes available another follow up report will be submitted.For additional information regarding the investigation and conclusion, please see manufacturer report 8020030-2017-00004 and follow up #01.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR,
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley; victoria, 3149 ; AS 3149
• MDR Report Key: 6267288
• MDR Text Key: 65408343
• Report Number: 1423337-2017-00001
• 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: 02/10/2017,12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PELORIS
• Device Catalogue Number: 26.0005
• 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: 02/10/2017
• Distributor Facility Aware Date: 12/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other