MAUDE Adverse Event Report: CLEARCUT KNIVES; KNIFE, OPHTHALMIC

Catalog Number	8065993047
Medical Device Problem Codes	Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health administrator reported that during a surgery an ophthalmic knife blade while making incision was found to be curled and performed irregular cuts.The surgery was completed by replacing a new knife.There was no patient harm reported.
Additional Manufacturer Narrative
A sample was not received, at the manufacturing site for evaluation.For the report of the blade was curled and could not perform cutting causing irregular cuts.Therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.A sample was not received, at the manufacturing site.And the device history record review of the lot number provided, indicated the product was processed and released according to the product¿s acceptable criteria.Therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown.Therefore, specific action with regards to this complaint cannot be taken.All knives are 100% inspected by trained operators using a minimum of 10x magnification, during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed, associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLEARCUT KNIVES
• Common Device Name: KNIFE, OPHTHALMIC
• MDR Report Key: 12251987
• Report Number: 2523835-2021-00273
• Device Sequence Number: 17355562
• Product Code: HNN
• UDI-Device Identifier: 00380659930478
• UDI-Public: 00380659930478
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 8065993047
• Device Lot Number: 13L8RA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 10/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1