MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER EDGEPLUS TROCAR/CANNULA SET; CANNULA, TROCAR, OPHTHALMIC

Catalog Number 8065751447

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  malfunction  

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 Description

A nurse reported the trocar puncture was too blunt and the surgeon found it was difficult to penetrate the scleral tissue during a procedure.The product was replaced with another one and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of the tip of the puncture is too blunt; 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.Because a sample was not received at the manufacturing site and the device history record review indicated that the product was processed and released according to the product¿s acceptance criteria, the exact root cause for this complaint is unknown.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A product sample has been received by the manufacturer and it is awaiting evaluation.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Three opened 23 gauge (ga) trocar assemblies were received.Sample #1 was visually inspected and was found to be nonconforming with a damaged tip and a damaged cutting edge.Sample #2 was visually inspected and was found to be nonconforming with a damaged tip.Sample #3 was visually inspected and was found to be conforming.Functional penetration testing was performed on sample #3 and was found to be conforming, the testing could not be performed on sample #1 and #2 due to the damage of the sample.The exact root cause could not be determined from the investigation performed.The damage to the returned samples is consistent with damage that can occur when the blade contacts a hard surface such as the protective cap, improper handling, or contact with another instrument during surgery or set-up.The damage seen on the returned complaint samples could have contributed to the customers reported issue of dull blade.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Any nonconformances, such as the damaged tip and damaged cutting edge are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).

• Brand Name: EDGEPLUS TROCAR/CANNULA SET
• Type of Device: CANNULA, TROCAR, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10270786
• MDR Text Key: 199475697
• Report Number: 2028159-2020-00525
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 8065751447
• Device Lot Number: 128EYK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1