MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH LEICA BIOSYSTEMS; LOW-PROFILE DISPOSABLE BLADES DB80LS (10X50)

Lot Number 118253

Device Problems Separation Failure (2547); Mechanical Jam (2983)

Patient Problem Laceration(s) (1946)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

Complaint data was reviewed from january 1st, 2017 to november 27th, 2018 and no other complaints were identified for this product lot that reported an issue with the dispenser.Product retains are currently being evaluated by the manufacturer.An investigation is currently underway and a follow-up will be submitted should additional information become available following the investigation.

Event Description

Customer's employee was attempting to dispense the disposable blades (lot 118253) and when it would not dispense the product, the customer attempted to pull the product from the dispenser.Once the attempt was executed, the employee experienced a cut on the finger and required emergency room medical attention in the form of stitches.Incident occured on (b)(6) 2018 and was reported to leica biosystems (b)(4) 2018.Additional information was required and was provided to leica biosystems (b)(6) 2018.Complaint record was created 11/09/2018.

Manufacturer Narrative

Additional manufacturer narrative the product code 14035843489 lot 118253-430 was returned to richmond by the customer for review by a leica biosystems engineer.A review of the dispenser against the dispenser drawings was completed by an r&d engineer on 11jan2019.The top of the dispenser in which the blade opening for separation of blades is housed was found to be to dimension stated in the drawing.The pusher which moves the blade forward is to dimension stated in the drawing.The blades are to the specification for thickness as stated in the drawing.The returned product was found to be conforming to the drawing dimensions.It was concluded by the engineer that the potential cause of the incident was human error.If the pusher is moved forward and then retracted without completing the dispensing cycle, the pusher engages a second blade.The pusher then cannot finish dispensing the first blade due to blockage of the blades in the blade separation opening.The user then had a partially dispensed blade remaining in the dispenser.Removal of the blade by hand without protection could potentially lead to a cut.No additional information is available at this time.Leica biosystems will continue to track and trend this complaint.

Event Description

Customer's employee was attempting to dispense the disposable blades (lot 118253) and when it would not dispense the product, the customer attempted to pull the product from the dispenser.Once the attempt was executed, the employee experienced a cut on the finger and required emergency room medical attention in the form of stitches.Incident occurred on (b)(6) 2018 and was reported to leica biosystems (b)(6) 2018.Additional information was required and was provided to leica biosystems (b)(6) 2018.Complaint record was created (b)(6) 2018.

Manufacturer Narrative

Correction: section d3 country correction from united states to germany a review of the manufacturing documents for product code 14035843489 lot 118253-430 was reviewed by the responsible manufacturing manager.Based on the review of the documents, they did not show any irregularity that could cause the failure of the blade dispenser.The product retains for product code 14035843489 lot 118253-430 was also evaluated by the responsible manufacturing manager for functionality.Based on the evaluation conducted, the retains properly dispensed and the blades did not show any irregularity that could cause the failure of the blade dispenser.The customer product was returned to leica biosystems richmond on 12/17/2018 and is currently being evaluated.Upon additional information becoming available, a follow up report will be submitted.

Event Description

Customer's employee was attempting to dispense the disposable blades (lot 118253) and when it would not dispense the product, the customer attempted to pull the product from the dispenser.Once the attempt was executed, the employee experienced a cut on the finger and required emergency room medical attention in the form of stitches.Incident occurred on (b)(4) 2018 and was reported to leica biosystems (b)(4) 2018.Additional information was required and was provided to leica biosystems (b)(4) 2018.Complaint record was created (b)(4) 2018.

• Brand Name: LEICA BIOSYSTEMS
• Type of Device: LOW-PROFILE DISPOSABLE BLADES DB80LS (10X50)
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH; heidelberger strabe 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 8112433
• MDR Text Key: 128665958
• Report Number: 1419341-2018-00004
• Device Sequence Number: 1
• Product Code: IDL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/20/2020
• Device Lot Number: 118253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention