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

Catalog Number 8065830047

Device Problem Failure to Cut (2587)

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

Event Date 03/03/2021

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 surgeon reported two vitrectomy probes did not cut during a procedure.The procedure was completed after replacing the product with a third one.There was no harm to the patient.This report is for one of the two vitrectomy probes.

Manufacturer Narrative

The returned sample was visually inspected and found to be non-conforming with the needle bent and orange/brown foreign material observed on the port face.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.At the time of receipt it was observed that the needle was bent and the radio-frequency identification (rfid) connectors were cut off.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.The port of the inner cutter was observed to deformed.The inner cutter was observed to be severely bent and gouge marks were observed along the majority of the length of the inner 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 (bent 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 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 most likely cause for the actuation failure is 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.An exact root cause for the bent needle and the bent inner cutter 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.Complaints are 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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• 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: 12019223
• MDR Text Key: 256840838
• Report Number: 1644019-2021-00409
• 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: 09/08/2021

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 Catalogue Number: 8065830047
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PACK; CONSTELLATION VISION SYSTEM; CONSTELLATION SURGICAL PROCEDURE PACK; CONSTELLATION VISION SYSTEM