MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS; HISTOCORE PEGASUS PLUS

Catalog Number 14048858005

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/15/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 leica biosystems (lbs) received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus.On (b)(6) 2023, the complainant initially reported to lbs that all tissue was diagnosable.However, on (b)(6) 2023 the customer informed leica biosystems, that ihc (immunohistochemistry) was unable to be properly performed and further recommended re-biopsy.One (1) breast specimen was not entirely diagnosable due to inability to run testing marker.When asked if the state of health of the patient had been adversely affected by a medical decision or action either taken or not taken due to this event, the complainant replied, "n/a although delays in care, full diagnosis and having to undergo another biopsy have all occurred.".

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.

Manufacturer Narrative

The investigation revealed the following: the investigation was headed by a leica biosystems shanghai senior quality engineer and supported by a leica field service engineer from the leica biosystems su usa.Based on the investigation, the incident was user related and was most likely be caused by an air tube blockage which in turn caused the instrument to report an error.This led to the affected tissue sitting idle for 2 hours in xylene in retort a, cause the observed tissue damage to occur.Given that the customer clearly indicated to always use a vent plug when adding fresh paraffin and that the leica field service engineer could observe a timely emptying of the condensate bottle, as well as wax chambers 1-3 having been observed to be overfilled, we believe the most likely root cause for this adverse event to be paraffin spillage into paraffin the bath air hole due to an excess of paraffin in the paraffin bath (higher than the recommended maximum line).Based on the investigation results, as well as the remedial actions carried out by the leica biosystems fse and fas, we as the manufacturer confirm the instrument is, at this point in time, working according to factory specifications.To avoid a recurrence of the same issue in the future, a customer facing letter was sent out to the customer with recommendation, to consider the countermeasures as defined in the instruction for use (ifu) regarding the air tube blockage.

• Brand Name: HISTOCORE PEGASUS
• Type of Device: HISTOCORE PEGASUS PLUS
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• Manufacturer (Section G): LEICA MICROSYSTEMS LTD. SHANGHAI; building 1, 258 jinzang road; shanghai,pudong, 20120 6; CH 201206
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 17892560
• MDR Text Key: 325237250
• Report Number: 8010478-2023-00011
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: (01)04049188216397
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14048858005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/07/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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): Other
• Patient Age: 67 YR
• Patient Sex: Female