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

Catalog Number 706.52

Device Problems Failure to Cut (2587); Difficult to Open or Close (2921)

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

Event Date 06/12/2018

Event Type  malfunction  

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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that an ophthalmic scissors could not cut, open or close during a vitrectomy surgery.The incision site had to be enlarged in order to remove the scissors device from the patient's eye with no report of further harm experienced.Additional information received clarified that the procedure time was prolonged while removing the scissors from the eye, but that resulted in no complications for the patient.

Manufacturer Narrative

Additional information is provided.Corrected information is provided in sections to correct the name of the product.The four received scissors samples were found in unopened, original packaging with cover foil.The complained instrument was not received.The samples were functionally and visually inspected with the aid of a photomicroscope with various magnifications.The customer¿s complaint was not confirmed.It was found that the returned samples meet specification.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 acceptance criteria.A 100% final inspection is performed for this product.A possible root cause could not be determined because the returned, unopened samples meet specification.No further actions will be issued.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: 7866088
• MDR Text Key: 120136850
• Report Number: 3003398873-2018-00027
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 706.52
• Device Lot Number: F138828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1