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

Model Number PELORIS

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided by the complainant, the tissue samples involved in this event were derived from the "6 hour cycle" protocol comprising 63 cassettes, which started in retort b at 18:45pm on 04 october 2019 and completed at 07:30am on (b)(6) 2019.The user response to the information detailed in association with the "1337" error code was not appropriate, which is not to use the instrument and to contact service.No other use error(s) was identified in the instrument logs in relation to the interaction between the user and the instrument either prior to, during execution of the "6 hour cycle" started in retort b at 18:45pm on 04 october 2019, from which sub-optimal tissue processing was reported.Investigation of this complaint found that the instrument functioned as designed during execution of the "6 hour cycle" protocol started in retort b at 18:45pm on 04 october 2019.The root cause of the sub-optimal tissue processing reported by the complainant is the use of formalin contaminated wax for the wax infiltration step of the protocol.The root cause of the wax contamination with formalin was failure of the user to follow the information displayed on the instrument monitor, which is not to use the instrument and to contact service, when the "1337" error which indicates a leaking retort wax valve occurred.The root cause of the "1337" error generated is a leaking retort b into the wax line due to a piece of string found in the retort b wax valve.

Event Description

The leica tac supervisor received a complaint detailing the following: "bad processing, wax valve leak error.Dry poorly fixed tissue on the periphery of the tissue.The lab staff have noted dry tissue and some difficulty sectioning.Wax found in ethanol and formalin bottles." on 22 october 2019, a leica field service engineer (fse) visited the customer site in order to assess the operation and function of the instrument.The fse performed visual inspection of the instrument and documented the following: "check wax content in wax chamber 1 to 4 found wax in wax chamber 3 (85%) and 4 (97%) is dirty, there is debris floating.Check reagent content bottle 1 to 16, found content in bottle 6 ethanol 96% should look clean and clear but it is milky, dirty, and slimy.Dismantle retort b wax valve found a piece of string blocking wax valve from closing properly which is the root cause for error 1337 retort wax valve leaking.Do not use instrument; contact service, retort b.Retort a wax valve, no debris found".On 22 october 2019, the leica product application specialist received information that all cases involved in this event were diagnosable.

• 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, 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, 3149 ; AS 3149
• MDR Report Key: 9319685
• MDR Text Key: 216896821
• Report Number: 8020030-2019-00043
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS
• Device Catalogue Number: 26.0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2005
• 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