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

Catalog Number	8065751768
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
An other healthcare professional reported that cutter tip was bent before the surgery.The surgery was completed by replacing the cutter.There was no patient contact.The procedure type was unknown.
Additional Manufacturer Narrative
One opened probe was received with no tip protector and the broken needle taped to the body of the probe, in a bag.The returned sample was visually inspected and found to be non-conforming with the probe needle bent and broken off at the stiffener.Disassembly activities and a wear evaluation were unable to be performed due to the visual condition of the probe.Photos of the label and product are attached to the parent file and have been reviewed by the investigation site.The product and lot information seen matches what was reported.The photos of the product show an opaque material covering the tip; therefore the reported bent tip could not be confirmed.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification (rfid) tag indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirms that the probe had a bent needle, and also indicated that the needle was broken off of the probe assembly.The exact root cause of the bent and broken needle 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.An exact root cause for the bent and broken needle 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
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18388741
• Report Number: 1644019-2023-01909
• Device Sequence Number: 2634964
• Product Code: LRO
• UDI-Device Identifier: 00380657517688
• UDI-Public: 00380657517688
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 8065751768
• Device Lot Number: 15A1L2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown