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

Model Number PELORIS II

Device Problem No Apparent Adverse Event (3189)

Patient Problem Pain (1994)

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

Information reported by the complainant details that a user sustained a "repetitive motion injury, accumulative" to the shoulder, which started three (3) weeks prior to (b)(6) 2022, when removing bottle number 1 from the instrument; the incident was submitted to employee health; the affected employee did not incur any lost time at work and no medical treatment was either administered or required.Manufacturer evaluation of the information available did not identify any evidence to suggest a malfunction of the instrument in the three (3) weeks prior to (b)(6) 2022, which was the time period nominated by the complainant as preceding the "repetitive motion injury, accumulative".

Event Description

The complainant contacted leica biosystems and local leica applications specialist-pathology documented the following: "employee injury, shoulder.Issue started about 3 weeks ago, employee reported to management today.Employee will seek medical support.Caller says that it is "repetitive motion injury, accumulative".Customer removed bottles (formalin) at which time noted some build up, dirty which was cleaned away." on 25 july 2022, leica representatives visited the customer site.The assigned leica field service engineer documented the following: the complainant had advised the injury occurred when changing the reagent in bottle 1 (formalin); bottle 2 formalin needed more force to pull out than bottle 1; routine preventive maintenance service was last performed with the service kit (containing o-rings) used on (b)(6) 2021; the o-rings "look good"; the spigots and instrument-side connections were "fairly clean" and had been cleaned by the complainant after the incident; there were no traces of lubricant were found on the o-rings of any of the bottles and the condition of all bottle grips and handles was "good with no damage".During the site visit, the assigned leica field applications specialist (fas) documented: "customer reports having issues removing bottle number 1 from instruments.The customer started changing formalin bottles on the instruments 3 weeks ago.Every week since the customer has had a hard time removing bottle number 1 from both peloris 2.Last week, the customer tweaked their shoulder attempting to remove bottle number 1.Customer could not remember exactly from which peloris 2.Has not caused them to miss any work.Has submitted incident to their employee health department and is waiting to hear back to see is [sic] they will need further medical evaluation." on 11 august 2022, leica biosystems melbourne received information from the local leica field applications specialist - core histology that no medical treatment was either administered or required.

• Brand Name: PELORIS II RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• MDR Report Key: 15256630
• MDR Text Key: 305355625
• Report Number: 8020030-2022-00092
• 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
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PELORIS II
• Device Catalogue Number: 26.0008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2013
• 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