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

Catalog Number 706.52

Device Problem Break (1069)

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

Event Date 12/20/2018

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 that the scissors broke in the patients eye during a procedure.The broken piece was removed from the eye.Patient harm was not reported.Additional information has been requested.

Manufacturer Narrative

The received sample was found with one bent scissor arm and one broken.The sample was found in the outer blister including cover foil.Surgery residuals were visible.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.The instrument was investigated.The sample was not returned properly and was probably additionally damaged during transport.The fracture surface did not show signs of corrosion.The straightness of the broken scissor blade, which was still inside the cannula, was investigated.It was found that the blade was still straight and not bent in an unusual manner.However, it was found that the fracture surface was just at the distal end of the cannula and on the same level as the bending of the second, not broken blade.Additionally, the fracture surface shows a fracture line that indicates that the fracture occurred from the middle to outside.The facts together lead to the conclusion that an external force bend both scissor blades.Since the inner blade bend around the rim of the cannula it broke off.A production or quality issue can be excluded.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

No sample received.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 manufacturing acceptance criteria.The manufacturer performs a 100% final inspection for this product.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).

• 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: 8272695
• MDR Text Key: 134309747
• Report Number: 3003398873-2019-00006
• 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: 05/07/2019

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: 06/30/2021
• Device Catalogue Number: 706.52
• Device Lot Number: F162153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 02/07/2019; 04/15/2019
• Supplement Dates FDA Received: 03/01/2019; 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR