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

Model Number PELORIS 11

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/20/2015

Event Type  Injury  

Event Description

Leica biosystems rec'd a complaint regarding suboptimal processing of tissue samples from two processing runs, which completed on (b)(6).The complaint requested the assistance of leica prod applications specialist.On (b)(4) 2015, leica biosystems rec'd info that a pathologist had reviewed the stained slides prepared from the affected tissue samples, and found that there were "some cases of undiagnosable tissue with re-biopsy possibly required." add'l info as to the number of pts for whom re-biopsy was recommended/required; and an identifier, the ager or date of birth and gender for each pt has been sought.On (b)(6) 2015, leica biosystems rec'd info from the complaint that re-biopsy of two pts had been performed.The age and gender for each of the two pts was provided.However, a pt identifier was no provided for either pt.Ref mfr report # 8020030-2015-00018 for details of the other pt involved.

Manufacturer Narrative

Investigation of this complaint found that the suboptimal tissue processing reported by the complainant was derived from the "dhm 6hr protocol" started in retort b at 21:46pm, on (b)(6)2015 and the "dhm 6hr protocol" started in retort a at 00:41am on (b)(6) 2015.The root cause of the sub-optimal tissue processing reported was a use error, which occurred prior to commencement of the "dhm 6hr protocol" started in retort b at 21:46pm on (b)(6) 2015.Specifically, the user incorrectly selected the option rather than the option when the dialog box was displayed on the instrument monitor.The option should only be selected when the entire contents of the reagent bottle have been replaced with fresh reagent.However, in this instance the user selected the option despite no change having been made to the reagent in bottle 5 (ethanol).This user action is not in accordance with the mfr instructions detailed in section 5.4.4 of the peloris/peloris 11 user manual.The

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY LTD; 495 blackburn rd.; mount waverley; victoria 3149 ; AS 3149
• Manufacturer Contact: 495 blackburn rd.; mount waverley; victoria 3149 ; 92117535
• MDR Report Key: 4694033
• MDR Text Key: 5644528
• Report Number: 8020030-2015-00022
• 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: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS 11
• Device Catalogue Number: 26.003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR