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

Catalog Number 8065751462

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/12/2021

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 plastic end of the trocar detached from the metal part during surgery.The product was replaced and the surgery was completed.There is no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation; however the attached customer photo confirms the reported issue of the plastic end detached from the metal part of the trocar.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 evaluation of the photo confirmed the reported customer complaint of the trocar cannula/hub became separated, however, since a sample was not received at the manufacturing site how and when the trocar cannula and hub became separated cannot be determined from this evaluation and the root cause for this complaint is unknown.A potential contributing factor of the separation is manipulation during surgery.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is 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).

Event Description

The event occurred during vitrectomy surgery.

Manufacturer Narrative

Three opened 25+ trocar assemblies in a small parts tray (smpt) within a tray were received.The returned trocar cannula/hub assemblies were visually inspected and were found to be conforming.The cannula/hub assemblies were then functionally tested with the push out test and were found to be conforming.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photo attached to the parent complaint was reviewed by the manufacturing site.The returned samples were found to be conforming, therefore the trocar plastic end detached from the metal part in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The attached photo confirmed the reported customer complaint of the trocar cannula/hub became separated, however, since the samples were received at the manufacturing site and found to be conforming how and when the trocar cannula and hub became separated cannot be determined from this evaluation and the root cause for this complaint is unknown.No action was taken as the trocar was manufactured to specifications.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is 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).

• 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
• 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: 12258576
• MDR Text Key: 264474859
• Report Number: 1644019-2021-00507
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657514625
• UDI-Public: 00380657514625
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2022

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 Expiration Date: 09/30/2022
• Device Catalogue Number: 8065751462
• Device Lot Number: 2421811H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 09/29/2021; 01/20/2022
• Supplement Dates FDA Received: 10/27/2021; 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1