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

Catalog Number 725.52P

Device Problem Break (1069)

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

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

No sample has been received by 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.(b)(4).

Event Description

A nurse reported that an ophthalmic scissors tip broke while in contact with the patient during vitrectomy surgery.There was no harm to the patient.Additional information received further clarified that the tip did break while inside of the patient's eye, but the broken tip was successfully removed from the eye.

Manufacturer Narrative

The received sample was found in the inner and outer blister without the 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 investigated instrument had one scissor blade broken off.As it was reported, by the customer.The instrument was investigated.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.Therefore, it can only be assumed that issue was caused afterwards during handling, but this can not be verified.The root cause was unable to be verified as no signs were found, indicating the cause of the fracture.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 and further action will be 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 ADVANCED DSP TIP SCISSORS
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 10200328
• MDR Text Key: 197103979
• Report Number: 3003398873-2020-00048
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 725.52P
• Device Lot Number: F187002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1