MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP300; TISSUE PROCESSOR, PRODUCT CODE: IEO,

Model Number 14047634101

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 06/29/2017

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

The customer reported that on (b)(6) 2017 they experienced suboptimal tissue processing on their leica asp300.As a result five tissue blocks were undiagnosable.Leica biosystems is trying to obtain the patient identifiers but at this time the customer is not able to provide this information, because to date no rebiopsy was required.

Manufacturer Narrative

The investigation revealed the following: the incident was presumably user related due to a wrong application from the customer site.The customer was performing a water flush from bottle 3 to clean the retort, and while the water was in the retort, another laboratory employee saw the empty bottle and replaced the bottle 3 with reagent alcohol.After the retort was drained, the reagent alcohol backed up in to the lines, air system, and all of the bottles.Then the customer ran the instrument without changing the bottles, and the baskets with the tissues were affected.The field service engineer inspected the instrument and verified the condition at customer site.He drained the condensate bottle and overfull trap bottle of the unit, cleaned the lines leading to trap bottle, disconnected the air lines in rear of system and drained the water from the pump.The field service engineer performed a smart clean on the instrument.Additionally the customer replaced the reagents on the unit and performed a clean on unit after performing a pressure test and a fill drain test.The unit is operating per manufacturers specifications.The customer did state they were recommending a rebiopsy, but this had not yet been performed.

• Brand Name: LEICA ASP300
• Type of Device: TISSUE PROCESSOR, PRODUCT CODE: IEO,
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 6787468
• MDR Text Key: 82456973
• Report Number: 8010478-2017-00006
• Device Sequence Number: 1
• Product Code: IEO
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 14047634101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other