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

Catalog Number 14048858007

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2024

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 08 march 2024, leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus plus, tissue processor.The customer informed leica biosystems, that as a result, 1 tissue sample have not been diagnosed.

• 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 ; nussloch 69226 ; GM 69226 ; 6224143345
• MDR Report Key: 19056906
• MDR Text Key: 339555147
• Report Number: 8010478-2024-00008
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769(11)230801
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 14048858007
• Distributor Facility Aware Date: 03/08/2024
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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 Age: 7 YR