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

Catalog Number 8065751462

Device Problem Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

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.(b)(4).

Event Description

A surgeon reported the trocar cannula separated from its hub when the knife penetrated it and the trocar was pulled out with the knife during a vitrectomy procedure.The product was replaced with another and the procedure was completed.There was no harm to the patient, no additional information is expected.

Manufacturer Narrative

Three opened trocar handle/blade assemblies, 1 opened trocar hub/cannula assembly, 2 opened hubs, and 2 opened cannulas were received for the report of trocar came apart and came out of incision.The returned hub/cannula samples were visually inspected.The trocar hub/cannula assembly (sample 1) was found to be conforming.The hubs and cannulas that were received separated (samples 2 and 3) were found to be non-conforming.The hubs returned with the cannulas separated had a presence of adhesive inside of the hubs.A functional push out test was performed on sample 1 and was found to be conforming.Photos attached to the parent complaint were reviewed by the manufacturing site.Photo 1 confirms the reported product and lot numbers photo 2 shows 2 separated trocar hub/cannulas.The hubs were separated from the cannulas.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.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.The evaluation of the returned samples identified adhesive inside of the hubs, therefore, 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.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.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: 8406201
• MDR Text Key: 138541769
• Report Number: 1644019-2019-00029
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 8065751462
• Device Lot Number: 2062975H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1