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

Catalog Number	14048858005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.".
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 8010478-2023-00011
• Device Sequence Number: 20685059
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: (01)04049188216397
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 14048858005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/07/2023
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female