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

Catalog Number 725.52

Device Problem Break (1069)

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

Event Date 06/23/2020

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported one of the two micro-scissor blades broke and fell on the patient's retina.It is unknown if the blade remains in the eye.Patient harm has not been confirmed.Additional information has been requested but not received.

Manufacturer Narrative

Additional information has been provided in h.6.And h.10.No sample received at the manufacturer.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 manufacturers acceptance criteria.A 100% final inspection for this product was performed.A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information has been provided in d.10., h.3., h.6.And h.10.The sample was received in the inner blister including cover foil.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The investigation on the cleaned instrument showed a broken scissor blade.The orientation of the second intact scissor blade indicated that no deformation occurred due to an external force before the second scissor blade broke off.The cross section off the broken blade showed no signs of corrosion; no defect on the outer surface which could initiate a crack was visible.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.A possible root cause could not be determined.It can only be assumed that the fracture took place after product inspection, however, this cannot been determined anymore.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER ADVANCED DSP TIP SCISSORS
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 10278079
• MDR Text Key: 199652824
• Report Number: 3003398873-2020-00062
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 725.52
• Device Lot Number: F173332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1