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

Catalog Number 705.52P

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/23/2018

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 nurse reported that during a vitrectomy procedure for the repair of a retinal detachment, the scissor broke in the eye.The broken part of the scissors was removed by the surgeon during the same surgery.The gesture lengthened the surgery time.The patient was very sore after the surgery and has to be kept in the recovery room for a longer time.

Manufacturer Narrative

Additional information has been provided.The received sample was found in the outer blister fixed with adhesive tape including cover foil.The sample was very bent one blade was broken off (not received the broken blade) and one blade was so damaged that it broke off during cleaning 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 manufacturer acceptance criteria.A 100% final inspection for this product.The complaint history was reviewed two years back.It showed three comparable complaints.The sample was visually inspected with the aid of a photomicroscope and with various magnifications.It was found that the scissors is bent and the two blades were broken off (one blade was so damaged that it broke off during cleaning).This broken blade could be investigated.The instrument was destroyed to investigate the fracture.One blade was broken at the edge of the tube.No signs of corrosion are visible.Therefore, the break must have been caused by external force.The other blade was broken some distance behind the other.The fracture looks the same as for the first blade.No signs of corrosions are visible.Therefore, the break must have been caused by external force.A 100% final test ensures that the instrument meets specifications after production.When and where the force has been applied to the forceps cannot be proven anymore.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information has been provided.A sample was not received for evaluation.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.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: 7796583
• MDR Text Key: 117848005
• Report Number: 3003398873-2018-00024
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• 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: 705.52P
• Device Lot Number: F137903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Date Manufacturer Received: 10/29/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR