MAUDE Adverse Event Report: CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065751063

Device Problem Failure to Cut (2587)

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

Event Date 04/13/2021

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 nurse reported that the probe did not cut.Aspiration was unknown.The probe was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of there was poor cutting with the probe; therefore, the condition of the product could not be verified.The product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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).

Manufacturer Narrative

One opened probe was received, with tip protector, in a tray along with other items.The sample was visually inspected and found to be nonconforming with orange/brown foreign material on port face, and white foreign material along needle, on tip and inside of needle.The sample was then functionally tested for actuation and cut.The sample was found to be nonconforming for both functional tests.The probe was disassembled and the components inspected.Excessive wear was observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouges marks were observed at the cutting edge and multiple other locations along the inner cutter.Orange/brown foreign material was observed towards tip of 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.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 complaint evaluation confirms the probe had a cut failure, and also indicated that the probe had an actuation failure.The root cause for the actuation and cut failures as well as the foreign material observed is due to the excessive surgical use of the probe.The vitrectomy portion of the procedure is typically less than 20 minutes and it appears that the probe has experienced a use much greater than this typical timeframe.The excess usage of the probe will wear and damage the inner cutter such that the cutter function becomes poor, bent, or does not function at all.No action has been taken as it appears that the observed actuation and cut failures were due to excessive use of the probe by the user.All 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 further actions are required.The manufacturer internal reference number is: (b)(4).

Event Description

The event occurred during a vitrectomy surgery.

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• MDR Report Key: 11683943
• MDR Text Key: 246034762
• Report Number: 1644019-2021-00262
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657510634
• UDI-Public: 380657510634
• 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,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 8065751063
• Device Lot Number: 2362480H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1