MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255

Model Number 1492255UL01

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.

Event Description

On (b)(6) 2020, leica biosystems received information via email from the complainant that users were being injured (cut) by the blade of microtome instruments.On 16 january 2020, leica biosystems received the following information from the complainant: "for one incident the employee sustained a cut to their right hand during the cleaning process.Guard was not lowered to check for the blade before cleaning.The second injury occurred on the tip of the employees left finger.Reportes; as they went to lift the blade guard their gown got caught on the handle of the bar resulting in a cut to the finger." on 17 january 2020, the complainant confirmed microtome model rm2255 was involved in the events but the two incidents occurred on different machines.The complainant also stated, "all of our employees seek first aid with the nurses on site, if they require further attention they visit their doctor." as of 26 january 2020, leica biosystems is still communicating with the complainant to obtain additional information regarding the specific microtomes involved and if any medical intervention/treatment was required for the users.

Manufacturer Narrative

On 19 february 2020, leica biosystems obtained the information below from the complainant.The microtome instruments involved in the two separate incidents are detailed below.For both incidents, no medical intervention, treatment or first-aid was necessary.Rm2255 sn:(b)(6).Doi: (b)(6) 2019.First aid: none.Rm2255 sn:(b)(6).Doi (b)(6) 2019.First aid: none.Following investigation of this event, the cause of the injuries (cuts) was presumably user error.The staff did not follow the safety instructions detailed in the microtome and blades instructions for use (ifu) and package insert.The customer did not wear safety gloves while using the instrument, as described in the ifu.As per the complainant, "we have already completed sop review and re training on the process and safe handling of the machine." no further action(s) by the manufacturer are required because the instrument was found to be operating within specification.The manufacturer will create a customer-facing report, in order to provide feedback regarding the circumstances involved in this complaint.

• Brand Name: LEICA RM2255
• Type of Device: LEICA RM2255
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 9699679
• MDR Text Key: 190824732
• Report Number: 8010478-2020-00002
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1492255UL01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other