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

Catalog Number 8065751077

Device Problems Sticking (1597); Dent in Material (2526)

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

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

An ophthalmic surgeon reported that the probe got stuck halfway into a trocar during a vitrectomy procedure.The probe tip was observed to have a dent.There was no known harm to the patient.The product sample is available.Additional information was requested; however, none has been received to date.

Manufacturer Narrative

A product sample has been received by the manufacturer and it is awaiting evaluation.(b)(4).

Event Description

The surgeon indicated the procedure was a phacoemulsification and vitreo-retinal procedure on the right eye and that the vitrectomy was not completed.

Manufacturer Narrative

The previous date rec'd by mfr provided in the supplemental medical device report #01 was incorrect.The correct date was 03/31/2017 not 03/27/2017.(b)(4).

Manufacturer Narrative

One probe sample was returned for evaluation for the report of the probe becoming stuck in the trocar due to a dent on the needle.A review of the device history records 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 were no additional complaints associated with the lot for the reported issue.Five photos were provided by the customer to show the dent on the needle indicated by the customer.No conclusion can be made that a dent is present based on the photos.A photo was also provided on the pak that provides the item and lot number for the complaint sample.The probe sample was visually inspected and was deemed nonconforming.Foreign material was present on the cannula surface in the middle region of the needle.No dent was present on the probe needle.The needle middle and body side outside diameter were measured and deemed conforming where no foreign material was present.The diameter in the central location of the needle where the foreign material was present was nonconforming.The diameter measurement, after the foreign material was wiped off, was conforming.The probe needle was fit tested for function into a conforming trocar and was deemed conforming after the foreign material was removed.The fit was initially nonconforming due to foreign material present on the needle.The complaint evaluation does confirm the vitrectomy probe was not able to be inserted into a trocar in the condition the probe was returned.The root cause for the difficult fit into the trocar appears to be from surgical material and does not point to a manufacturing issue.The source of the foreign material cannot be determined from this evaluation.The dent indicated by the customer was actually where the foreign material was present on the needle.No specific action with regard to this complaint could be taken because the root cause for the foreign material that was associated with the complaint issue cannot be determined from this complaint.All probes are 100% visual inspected during the manufacturing process for excessive manufacturing materials on the needle.All assembled probe needle diameters are also 100% tested for fit into a ring gauge to insure the probe needle does not exceed a trocar opening.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.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, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6427588
• MDR Text Key: 70979946
• Report Number: 1644019-2017-00284
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 8065751077
• Device Lot Number: 1918281H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 69