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

Catalog Number 705.52P

Device Problem Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

The received scissors sample was received in the opened, original packaging including the cover foil.The sample shows signs of use due to surgery residuals.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The scissor could not be activated because of surgery residuals.After cleaning, it could be activated, but stuck in the closed position because the extension tube moves forward.The customer¿s complaint was confirmed.It was found that the tube is loose and blocks the scissor by activating.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.The complaint history was reviewed two years back.It showed one comparable complaint.No adverse trend observed.It cannot be excluded that the metal tube loosened and therefore, a proper activation was no longer possible.This kind of damage was already detected and investigated.The root cause could not be identified conclusively, but the most likely root cause can be determined to be an improperly performed bonding procedure.Based on the available data this is a single event for this finished product lot.The currently valid risk analysis considers the possible risks related to the reported event.With this single case and one related complaint within a time range of 24 months, the likelihood of occurrence of the hazard that may cause a patient harm is assessed in the risk management report.The final risk is considered as low, remains unchanged and at an acceptable level.Future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that an ophthalmic scissors device kept its tip in the closed position prior to surgery.An alternate scissors was obtained in order to subsequently begin and complete the procedure.As there was no contact between the unsatisfactory scissors and the patient, there was no impact to the patient.

• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 8115772
• MDR Text Key: 128901898
• Report Number: 3003398873-2018-00039
• 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: Physician
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 705.52P
• Device Lot Number: F140797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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