MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER EDGEPLUS VALVED ENTRY SYSTEM; CANNULA, TROCAR, OPHTHALMIC

Catalog Number 8065751586

Device Problems Device Damaged Prior to Use (2284); Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2017

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 healthcare professional reported that one trocar was immediately blunt after the cap was removed; it was not possible to make a port with it.Event timing, procedure impact and patient outcome are unknown.Additional information has been requested but not received.

Manufacturer Narrative

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 complaint history examination indicates there is one additional complaint associated with the lot for the reported issue.Two full trocar assemblies were received for evaluation, the samples were visually inspected.One sample was non-conforming with a damaged tip and a damaged cutting edge.One sample was non-conforming with a damaged tip and a dull cutting edge.Penetration testing could not be performed due to the damage of the sample.Further evaluation showed that the samples appear to have been used.The samples were returned opened and the evaluation shows that they appear to have been used.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 dull cutting edge seen on one of the samples during the evaluation could have been cause during use.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 by trained operator for damaged and/or dull cutting edges and tips.Any nonconformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Product manufacturing site updated due to receipt of additional information.Additional information was provided.Manufacturer report number corrected and reported under 2028159-2017-04532.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received.The blunt trocar was noted during a pars plana vitrectomy procedure.It was reported that it looked like it had fallen on its tip.It did not come into contact with the patient and there were no negative consequences for the patient.The trocar was replaced, but the same issue was presented.A third trocar was used to complete the procedure.

• Brand Name: EDGEPLUS VALVED ENTRY SYSTEM
• Type of Device: CANNULA, TROCAR, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7052763
• MDR Text Key: 93196856
• Report Number: 1644019-2017-00805
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2018
• Device Catalogue Number: 8065751586
• Device Lot Number: 16040302X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR