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

Catalog Number 711.53

Device Problem Difficult to Open or Close (2921)

Patient Problem Tissue Damage (2104)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

A sample is available that has not yet been received at manufacturing for evaluation.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 physician reported that an ophthalmic scissors tips became unable to close while in use inside of the patient's eye during a combination cataract and vitrectomy surgery.The surgery was completed after treatment with an additional laser.There was no report of any patient harm.Additional information has been requested.Additional information received further clarified that the ora serrata retina had a hole when the tip of the inserted scissors had to be forcefully removed from the eye.

Manufacturer Narrative

A sample forceps was received in inner and outer blister, without the cover foil.The returned sample is very bent.A usb stick was also received.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 and with various magnifications.It was found, that the shaft is very bent as well, as the scissors blades.The returned device shows surgery residuals.Due to the condition of the sample, the customer's complaint could not be confirmed.The bending does not allow for a detailed examination of the root cause.On the received picture from the file and usb device, the lower blade looks bent and cracked, due to the geometry, but it cannot be determined if it is just an optical illusion.If it is actually bent, then this may have been caused by user handling.For example, while inserting through the trocar.The root cause for the reported event could not be determined conclusively, due to insufficient sample.A manufacturing or design related root cause for the damage of the complained device has not been identified.This complaint has been reviewed and future data will be monitored for evidence of adverse trending with further action taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.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: 10876569
• MDR Text Key: 217424329
• Report Number: 3003398873-2020-00137
• 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
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 711.53
• Device Lot Number: F183118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention