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

Catalog Number 706.52

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2019

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 reported that during a vitrectomy procedure a fragment of the micro scissors broke and fell into the back of the patient's eye.The fragment was retrieved in one piece, nothing was left behind during the original procedure.There was no harm to the patient.Additional information has been requested and received.

Manufacturer Narrative

The received sample was found in the inner blister including cover foil.The instrument shows surgery residuals.The broken part was also returned.The device history record for the affected lot was reviewed.No abnormalities that could have contributed to this event were found and the product was released according to manufacturer's acceptance criteria.The manufacturer performs a 100% final inspection for this product.One scissor blade was broken off as it was complaint by the customer.The instrument was visually inspected with the aid of a photomicroscope and with various magnifications.The fracture surface did not show signs of corrosion.Further signs indicating the cause of the fracture were not found during the investigation.A 100% functional test is performed during production, which ensures that the instrument fulfills the specification before it will be delivered.The cause of the fracture cannot be determined anymore.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: 8758445
• MDR Text Key: 150126909
• Report Number: 3003398873-2019-00057
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 706.52
• Device Lot Number: F165009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1