MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

Model Number 14049543267

Device Problems Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Date 03/01/2019

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)2019, leica biosystems received a complaint that they experienced suboptimal tissue processing on their asp6025.On (b)(6) 2019 the customer informed leica biosystems that 152 cassettes were affected, of which 86 were biopsies, and 86 patients had to be rebiopsied.

Manufacturer Narrative

Therefore my modified additional manufacturer narrative: the investigation revealed that this was an isolated issue.An instrument valve was inspected by a leica biosystems product specialist at the contract manufacturing site in shanghai.Based on the evaluation, the valve had a blockage caused by a metal burr which lead to cross contamination of the reagents.The instrument valves in stock at the manufacturing site were also checked for burrs with the result that no further valves were affected.A process to ensure valves are free of foreign particles before assembly has been established at the supplier site.Additionally, an incoming goods inspection process to check the valves for foreign particles has been established at the manufacturing site.History: supplement 1: (correction).Field b4: 29-aug-2019.Field g7: follow-up #: 02.Field h2: correction.Field h6: device code: 3049-527.Field h6: method code: 10.Supplement 2: (correction).Field b4: 30-aug-2019.Field g7: follow-up #: 03.Field h6: device code: 1384 - 2983.Supplement 3: (correction - according the support of the cesub team).Field b4: 10-sep-2019.Field g7: follow-up #: 04.Field h6: device code: 3049-527-2983.Field h10: corrected data.Supplement 4: field b4: 12-sep-2019.Field g7: follow-up #: 01.Field h2: additional information.Field h10: history.

• Brand Name: ASP6025
• Type of Device: ASP6025
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 8477025
• MDR Text Key: 140732691
• Report Number: 8010478-2019-00004
• Device Sequence Number: 1
• Product Code: IEO
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 14049543267
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other