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

Catalog Number 8065830077

Device Problem Failure to Cut (2587)

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

Event Date 04/12/2021

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 customer reported the cutter failed to cut during a procedure.The procedure was completed after product replacement.The involved eye and the patient identifier were not available.There was no patient harm.

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6., and h.10.   two opened probes were received with tip protectors, in trays.Sample #1 was visually inspected and found to be non-conforming with the needle slightly bent orange/brown foreign material on the port face.The sample was then functionally tested for actuation and cut and was found to be conforming for both functional tests.Sample #2 was visually inspected and found to be non-conforming with the needle slightly bent orange/brown foreign material on the port face.The sample was then functionally tested for actuation and cut.The sample was found to be conforming for cut and non-conforming for actuation.Sample #2 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.The inner cutter was observed to be severely bent and gouge marks were observed at several locations along the cutter.The sample was retested for actuation with the probe driver and was able to actuate.The initial actuation test failed due to an interference within the probe and once the interference (needle assembly) was removed the probe was able to actuate.The product was processed and released according to the product¿s acceptance criteria.The complaint evaluation does not confirm that either of the returned probes had a cut failure.The evaluation indicated that sample #2 had an actuation failure.The cut functionality of sample #2 was conforming, however, the observed actuation failure could have caused the probe to not cut at the time the reported event was observed.The most likely cause for the actuation failure is from the bent needle and bent inner cutter.A bent needle can impede the movement of the cutter shaft.This interference is present as observed from visual condition of the inner cutter.After the probe was disassembled (bent needle assembly removed), the probe was able to actuate.The exact root cause of the bent needle and bent inner cutter cannot be determined from this evaluation.The most likely root cause is handling at any point after the probe was shipped from the manufacturing site, including use during surgery.The reported cut failure was not confirmed and an exact root cause for the bent needle and the bent inner cutter in sample #2 was not determined from this evaluation, therefore, no specific action with regard to this complaint was taken.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received that two cutters failed to cut during a procedure.

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11791244
• MDR Text Key: 249681045
• Report Number: 1644019-2021-00312
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380658300777
• UDI-Public: 00380658300777
• 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
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 8065830077
• Device Lot Number: 2416676H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1