MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS; PROCESSOR, TISSUE, AUTOMATED

Model Number HISTOCORE PEGASUS

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2024

Event Type  Injury  

Event Description

On (b)(6) 2024 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus.As a result, 3 tissue samples need to be recollected (2 gastric biopsy samples and 1 esophageal sample).

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.

• Brand Name: HISTOCORE PEGASUS
• Type of Device: PROCESSOR, TISSUE, AUTOMATED
• 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; 20120 6; CH 201206
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch ; 6224143345
• MDR Report Key: 18814625
• MDR Text Key: 336615263
• Report Number: 8010478-2024-00003
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HISTOCORE PEGASUS
• Device Catalogue Number: 14048858005
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/02/2024
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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