MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER ACCURUS SURGICAL SYSTEM PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065750828

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

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.(b)(4).

Event Description

A nurse reported that during a vitrectomy procedure, the vitrectomy probe actuator would not open after closing, despite successfully priming.An alternate probe was used to complete the case.There was no harm to the patient.

Manufacturer Narrative

The sample has been received and in-house evaluation is in progress.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.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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

One opened probe was received, with a tip protector in a tray.Along with other items, for the report of would not open after closing.The returned sample was visually inspected and found to be conforming.The sample was then functionally tested for actuation, aspiration, and cut.The sample was found, to be non-conforming for actuation and aspiration.The cut functionality of the returned probe was unable to be tested, due to the actuation failure.The sample was then disassembled.And the components inspected.No/minimal wear was observed, on the inner cutter when compared to the degree of wear, based on continuous actuation of the probe visual standard photos.Gouge marks and wear marks were observed, at multiple locations along the inner cutter.The spring, diaphragm, o-ring, and spacers were all observed to be intact.After testing and disassembly were performed, the investigator realized, that the air connection to the probe driver was off.Therefore, the functional results are inconclusive.The probe was visually conforming.And all internal components and bonds were intact.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.The sample evaluation test results were deemed inconclusive.Therefore, a confirmation of the reported event could not be determined.And the exact root cause of the complaint could not be verified.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACCURUS SURGICAL SYSTEM PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10573536
• MDR Text Key: 208718873
• Report Number: 2028159-2020-00761
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 8065750828
• Device Lot Number: 17036814X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR