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

Catalog Number 705.52

Device Problem Dull, Blunt (2407)

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

Event Type  malfunction  

Event Description

A health care professional reported that an ophthalmic scissor was found to be sharpless and hard to use.Procedure details and patient impact were not reported.Additional information has been requested none received till date.

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.A sample has been received by manufacturing that has not yet been evaluated.The manufacturer internal reference number is: (b)(4).

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 was received in its outer blister and cover foil but without the inner blister.Instead, the tip with the scissors was embedded in a tissue.The sample shows macroscopic signs of damage: the shaft is extremely bent.However, it is unclear whether the damage a) occurred during shipment due to improper protection of the instrument without the inner blister, b) was intentionally put onto the device after the malfunction occurred to clearly discern it as a bad sample on the or table, or c)happened during surgery and is a contributing factor to the reported malfunction.During unpacking of the device and removing the tissue from the tip, the device broke.Therefore, no further sample evaluation is possible and the malfunction could not be confirmed nor could a root cause be identified.A root cause for the customers reported event could not be determined due to sample damage during unpacking.No root cause or contributing factors could be identified during the investigation of this case.Therefore, no actions are required.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: 17736800
• MDR Text Key: 323283676
• Report Number: 3003398873-2023-00193
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 07612717064638
• UDI-Public: 07612717064638
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 705.52
• Device Lot Number: 142L5H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1