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

Catalog Number 8065750157

Device Problem Dull, Blunt (2407)

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

Event Date 03/24/2021

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 physician reported that cutter was blunt during surgery.The condition of aspiration and actuation was unknown.The product was replaced and the procedure was completed.There is no patient harm.

Manufacturer Narrative

One opened probe was received with a tip protector, in a tray, for the report of poor cutting.The sample was visually inspected and found to be non-conforming with cracks in the housing and clear foreign material in the port and on the tip of the needle.The sample was then functionally tested for actuation and cut.The sample was found to be non-conforming for actuation.The cut functionality of the probe was unable to be tested due to the actuation failure.The probe sample 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.Gouge marks were observed at the cutting edge and a couple other locations along the inner cutter.The diaphragm, spring, o-ring, and spacers were all intact.The product was processed and released according to the product¿s acceptance criteria.The complaint evaluation indicated that the 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 root cause for the actuation failure, as well as the impact of the cracked housing, cannot be determined from the evaluation performed.The exact root cause of the actuation failure could not be determined from the evaluation performed, therefore, no specific action with regard to this complaint was taken by the manufacturing site.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will be continued to be 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 further actions are required.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: 11629870
• MDR Text Key: 244382908
• Report Number: 1644019-2021-00239
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657501571
• UDI-Public: 380657501571
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 8065750157
• Device Lot Number: 2312171H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1