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

Catalog Number 8065752435

Device Problem Detachment of Device or Device Component (2907)

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

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 the probe shell fell off during a vitrectomy procedure.Additional information received from the physician who reported the product was replaced with another one and the procedure was completed.There was no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation; however, the attached customer photo confirms the report of shell fell off.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The report of shell fell off is confirmed based on the photo.However; because a sample was not received at the manufacturing site and no lot information was provided, the root cause for the customer complaint issue cannot be determined the cause of the reported event cannot be determined with the information obtained; 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 further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• MDR Report Key: 12219566
• MDR Text Key: 263407197
• Report Number: 1644019-2021-00490
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524358
• UDI-Public: 00380657524358
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

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: 8065752435
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1