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

Catalog Number 705.52P

Device Problems Defective Device (2588); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 physician reported that during a vitrectomy an ophthalmic scissors was unable to open and close and while trying to open the tip of the scissor came off.The tip was able to be removed after widening the port and the surgery was completed after replacing the product with another one.There was no harm to the patient.

Manufacturer Narrative

A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The sample received with inner blister, outer blister and without cover foil.The sample shows macroscopic signs of damage.One blade of the scissors is broken.The sample shows no signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The sample was visually inspected.It was noticed that one blade of the forceps is broken.As the blister was opened by the customer, he handled the product.The point in time when the malfunction occurred, can no longer be determent.The customers complaint is confirmed it cannot be determined how or where the damage to the sample occurred; therefore a root cause for the customers reported event could not be determined.However, the damage was consistent with damage that can occur due to improper handling.The exact root cause for the customers reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17069729
• MDR Text Key: 316593872
• Report Number: 3003398873-2023-00056
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 07612717070691
• UDI-Public: 07612717070691
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 705.52P
• Device Lot Number: 141TX8
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1