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

Catalog Number 705.52P

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

A sample is available that has not yet been received by manufacturing for evaluation.The device history record for the affected lot was reviewed.No abnormalities that could have contributed to this event were found in the production documentation and the sample was released according to acceptance criteria.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.A 100% final inspection for this product.(b)(4).

Event Description

A doctor reported that an ophthalmic scissors was unable to close prior to surgery.There was no patient involvement therefore, no impact to any patient.Additional information has been requested.

Manufacturer Narrative

The customer returned a curved scissors sample for evaluation.The sample was received in the original package including cover foil.After cleaning, the sample was visually inspected with the aid of a photomicroscope with various magnifications.It was found that the scissors is bent.The complaint history was reviewed two years back.It showed three comparable complaints with bent scissors blade.It cannot be determined exactly how or when the damage occurred however, the damage to the complained sample is consistent with damage that can occur due to external force.A manufacturing or design related root cause for the damage of the complained device has not been identified.Possible root causes related to external impact which leads to this kind of damage could not be determined.The manufacturer has no influence on complaints which are in relation to external force.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
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6708599
• MDR Text Key: 79952632
• Report Number: 3003398873-2017-00019
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• 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: F137902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other