MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON INFINITI SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065750157

Device Problem Failure to Cut (2587)

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

Event Date 07/30/2020

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 customer reported that actuation/cutting failed during surgery.The surgery was completed after replacing the product with another one.There was no patient harm.The condition of aspiration is unknown.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.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.One opened probe was received with no tip protector, in a tray, for the report of actuation and cutting failure during surgery.The returned sample was visually inspected and found to be non-conforming with the inner cutter in the port of the needle.The sample was then functionally tested for actuation, aspiration, and cut.The sample was found to be non-conforming for actuation and aspiration with the inner cutter remaining in the port of the needle during testing.The cut functionality of the returned probe was unable to be tested due to the actuation failure.The probe was 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.Wear marks were observed at one location along the inner cutter.The o-rings, spacers, spring, and diaphragm are all intact.The complaint evaluation confirmed that the returned probe had an actuation failure.The cut functionality of the returned probe was unable to be tested, however, the observed actuation failure would have led to the reported cut failure.The cause of the observed aspiration failure is the inner cutter remaining in the port of the probe needle, due to the actuation failure, and obstructing aspiration flow through the probe.The cause for the actuation failure is the observed wear on the inner cutter of the probe.A worn inner cutter can impede the movement of the cutter shaft.How and when the inner cutter of the probe became worn cannot be determined form this evaluation.No specific action with regard to this complaint was taken by the manufacturing site because the exact root cause for the actuation failure cannot be determined from this evaluation.All probes are 100% tested for actuation, aspiration, and cut during manufacturing.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).

• Brand Name: INFINITI SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 10414071
• MDR Text Key: 203710682
• Report Number: 1644019-2020-00437
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 8065750157
• Device Lot Number: 2266083H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASSY, SHIP, OZIL INFI JAPAN