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

Catalog Number 8065751618

Device Problem Difficult To Position (1467)

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

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 customer reported surgeon had "trouble when trying to place instruments in and out of the sheath and did not get the micro-vitreous probe out." it was informed that the surgeon "had to put three trocars in during the case." additional information and product sample have been requested for evaluation.No updates have been received at this time.

Manufacturer Narrative

Two opened trocars were received for the report of difficulty inserting and removing instruments.The returned samples were visually inspected.One sample was conforming and one sample was non-conforming with a smashed hub, which does not contribute to the reported issue.Procedural residue was found in the cannula of each trocar.Both samples were then dimensionally inspected for cannula identification and were both found conforming.A review of the related device history records for the reported lot number indicates that the product was processed and released according to the products acceptance criteria.This evaluation does not confirm the difficulty inserting and removing instruments as reported by the customer.Procedural residue was found inside both cannulas received and evaluated by the investigation site.The returned samples were visually conforming for all attributes associated with the reported issue and were also dimensionally conforming for cannula identification, therefore, an exact root cause could not be determined as to why there was difficulty inserting and removing instruments through the returned samples.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Furthermore, one probe sample was returned for evaluation for the report of the probe being unable to insert into a trocar cannula.A review of the related device history records for the reported lot number indicates that the product was processed and released according to the products acceptance criteria.The probe sample was visually inspected and was deemed conforming.The needle has a very slight bend that is considered acceptable.The needle middle, body side, and distal tip outside diameters were measured and deemed conforming.The probe needle was fit tested for function into a conforming trocar and the fit was deemed conforming.The complaint evaluation does not confirm the vitrectomy probe was not able to be inserted into a trocar.The probe needle dimensions were to specification and the probe was able to enter a trocar.The reason for why the customer could not get the probe to enter the trocar cannot be determined from this evaluation.(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: 5883674
• MDR Text Key: 53343736
• Report Number: 1644019-2016-01124
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2016

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: 03/31/2018
• Device Catalogue Number: 8065751618
• Device Lot Number: 1876753H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2016
• 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