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 Problem No Code Available (3191)

Event Date 12/13/2016

Event Type  Injury  

Event Description

Leica biosystems received a complaint regarding sub-optimal tissue processing of approximately 92 blocks.On 27 december 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".Information as to whether medical intervention was required to preclude permanent impairment of a body function or permanent damage to a body structure will be sought.Investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

The initial 30-day fda 3500a report cited (b)(6) 2016 as the date of event (mm/dd/yyyy) and date received by manufacturer (mm/dd/yyyy).Investigation of this complaint determined the actual date of event (mm/dd/yyyy) and date received by manufacturer (mm/dd/yyyy) is 12/14/2016.The root cause of the sub-optimal tissue processing reported by the complainant was using ethanol with a concentration of 69.7% from bottle 3 for the final dehydration step of the "factory 2hr xylene standard" protocol comprising 92 cassettes, which started in retort a at 17:51pm on (b)(6) 2016 and completed at 06:00am on (b)(6) 2016.The minimum final reagent concentration required for ethanol is 98%.The consequences of using reagent at a concentration less than the minimum required for the final dehydration step in a protocol is re-introduction of water into the tissue which cannot be displaced in subsequent processing steps; and contamination of reagents used in the subsequent processing steps, ultimately resulting in sub-optimal tissue processing.The reagent in bottle 3 was replaced and the properties of the corresponding reagent station reset at 17:48pm on (b)(6) 2016.Bottle 3 was subsequently scheduled for use for the first time in the final dehydration step of the "factory 2hr xylene standard" protocol started in retort a at 17:51pm on (b)(6) 2016.Although the measured ethanol concentration in bottle 3 was 69.7% following completion of this protocol, the ethanol concentration in bottle 3 calculated by the instrument software was 100%.This finding indicates that a user had filled bottle 3 with 70% ethanol when the default concentration configured for this bottle was 100%.Investigation showed it was likely that the user filled bottle 3 with 70% ethanol because prior to replacement of the hard disk drive (hdd) on (b)(6) 2016, the configuration of the reagent stations had been customized such that bottles 3 and 4 were designated as 70% ethanol.The hard disk drive (hdd) in this instrument had been replaced by a leica field service engineer on 09 november 2016, because it had failed.The instrument configuration at the completion of this service activity was the manufacturer default for xylene processing ie.Bottles 1 and 2 designated as formalin; bottles 3-10 inclusive designated as ethanol; bottles 11-14 inclusive designated as xylene, bottle 15 designated as cleaning ethanol and bottle 16 designated as cleaning xylene.The default concentration for all bottles and waxes in the manufacturer configuration is 100%.However, it was not identified that prior to replacement of the hdd the configuration of the reagent stations had been customized such that bottles 3 and 4 were designated as 70% ethanol, which meant that the default concentration for these bottles was 70%.

Event Description

Information provided by the complainant to a leica field support specialist (fss) indicated that the tissue samples exhibiting sub-optimal processing were derived from a "factory 2 hr xylene standard" protocol which started on (b)(6) 2016 and completed at 06:00am on (b)(6) 2016.The affected tissue samples were described as "horrendous to cut"; and were noted to be shrinking in the blocks.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.

• 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
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149 ; 92117535
• MDR Report Key: 6248389
• MDR Text Key: 64713344
• Report Number: 8020030-2017-00004
• 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: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention