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

Catalog Number 8065752448

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

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 that the outer needle was moving forward and backward, and was in a state where it was hitting idle.The needle part (metal part) seemed to come off the handle during surgery.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

One opened probe was received with a tip protector, in a bubble bag, for the report of the needle (metal part) came off of the handle during surgery.The returned sample was visually inspected and found to be non-conforming with orange/brown foreign material on the port face.In order to further investigate the reported event, the returned probe was actuated and the probe needle/stiffener assembly was observed to have pulled out of the needle holder when actuated.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.Gouge marks were observed at several locations along the inner cutter.No lot number was identified with this complaint; however, a review of the device history records traceable to the lot number obtained from the customer returned device¿s rfid tag indicates that the product was processed and released according to the product¿s acceptance criteria.The evaluation confirms the reported issue of needle came off the handle.The exact root cause of the component detachment cannot be determined.An internal investigation has been initiated in order to investigate the component separation.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION 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: 10367197
• MDR Text Key: 202705776
• Report Number: 1644019-2020-00409
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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: 8065752448
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION, TABLETOP, JAPAN.