MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TOP NEEDLE; SURGICAL ADJUNCTS

Model Number TOP27G22

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown, not provided.If implanted, give date: not applicable.If explanted, give date: not applicable.(b)(6).Device manufacture date: unknown.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a customer ordered top needle angle 27g22 and the customer received top27g22, lot-5k08m.However, the label on the tyvek pack of the inside product was top needle straight 27g26(top27g26), lot-5l01m.No patient injury reported.No patient contact reported.No additional information was provided.

Manufacturer Narrative

Corrected data: upon further review of this file it was determined that the initial mdr was filed in error.The reported device is not same or similar to a product distributed/ sold in the united states.Device evaluation: the returned product was received at the manufacturer.There were no manufacturing errors identified on the returned product.Therefore, no product deficiency was identified.This may have been a user error issue.Additionally, there were no discrepancies or defects found during the manufacturing record review (mrr).The documentation shows that the production order was manufactured according to specifications.Based on the investigation results there is no indication of product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TOP NEEDLE
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5810047
• MDR Text Key: 50075811
• Report Number: 3004750704-2016-00013
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

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: Physician
• Device Expiration Date: 08/31/2020
• Device Model Number: TOP27G22
• Device Lot Number: 5K08M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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