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

Catalog Number 705.52P

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 03/22/2017

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 the manufacturer's acceptance criteria.A 100% final inspection is performed for this product.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.(b)(4).

Event Description

A materials manager reported that a pair of ophthalmic scissors would not work when the package was opened prior to surgery.An alternate pair of scissors was obtained prior to starting the procedure.There was no patient involvement with the unsatisfactory scissors.

Manufacturer Narrative

The customer returned a sample of disposable curved scissors to manufacturing for evaluation.The sample was received inside of a plastic bag.The tip was protected with foam.The sample was visually inspected.The customer¿s complaint was confirmed.It was not able to close the instrument.The sample has been destructively investigated.The first inspection showed that the insert and the extension tube were no longer fixed in the handle.The assumption was that no glue would be found on the shaft and in the handle, but the investigation shows glue residuals on the appropriate position in the handle.This demonstrates that the gluing process was applied appropriately.The stability of the gluing process for the extension tube was investigated in the vd-252-a.It was investigated if there is any influence on the gluing process which might reduce the final quality.No negative influence was found therefore, the gluing process can be considered as a stable and safe process.The destructive investigation did not determine the cause of the complaint.It is clear that the connection between the insert and the handle failed, but the root cause could not be identified.Due to the sign of use, the scissors worked once otherwise it is not possible to get in to the trocar cannula.This is the sixth complaint for this kind of issue in the last two years.No further actions are issued.The manufacturer internal reference number is: (b)(6).

• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6463376
• MDR Text Key: 72207630
• Report Number: 3003398873-2017-00006
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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: F137903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2016
• 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