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

Catalog Number 725.52P

Device Problem Break (1069)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

A physician reported that tip of the ophthalmic blade was broken in the patient's eye (unknown) during removal of the proliferative membrane on vitrectomy surgery, it was removed by using the forceps.The procedure was completed after replacing the other.There was no patient harm reported.

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).

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The investigation is concluded based on the sample evaluation outlined below.The sample was received in its inner and outer blister and with the cover foil showing the batch information.The sample evidently shows macroscopic signs of damage, namely that one of the scissor blades is broken off.It shows no signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope under various magnifications.The fractured surface is within the shaft and can therefore not be inspected.There are no abnormalities that would indicate a root cause for the breakage.As the blister was opened by the customer and per the initial report description, the product was handled and used on a patient.The situation in which the malfunction occurred can no longer be determined, nor can the strain put on the device be reconstructed.The customer¿s complaint is therefore confirmed but the root cause cannot be identified by this investigation.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.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 ADVANCED DSP TIP 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: 18319407
• MDR Text Key: 330946587
• Report Number: 3003398873-2023-00221
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 07612717071070
• UDI-Public: 07612717071070
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 725.52P
• Device Lot Number: 1562TJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1