MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER REVOLUTION DSP SCISSORS; SCISSORS, OPHTHALMIC

Catalog Number 705.52P

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2019

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 customer report that the scissors made a "click" sound and they did not close all the way before a vitrectomy procedure.There was no patient involvement.

Manufacturer Narrative

The received sample was found in the opened original packaging incl.Cover foil.It shows signs of use due to surgery residuals.The sample was visually inspected with the aid of a photomicroscope and with various magnifications.Due to the condition it can not be activated as expected and a clicking sound was hearable.The customer¿s complaint was confirmed.But it shows signs of use due to surgery residuals.After cleaning they are no more visible.The device history record for the affected lot was reviewed.The product was released according to acceptance criteria.A 100% final inspection was performed for this product.A 100% inspection and a qc inspection in the production process ensure that a deformed instrument will be detected in production.Therefore, it can be concluded that the instrument has been deformed by an external force during use.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER REVOLUTION DSP SCISSORS
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 8547374
• MDR Text Key: 143225078
• Report Number: 3003398873-2019-00028
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 705.52P
• Device Lot Number: F140797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1