MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER PNEUMATIC HANDPIECE DSP; UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE

Catalog Number 725.03

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

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

Event Date 02/16/2023

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 customer reported that ophthalmic handpiece tip locking part was not properly engaged and could not be locked when opened.The surgery was performed and completed after replacing the product with another one.The procedure type is unknown.The involved eye and the patient identifier are not available.

Manufacturer Narrative

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 with inner blister, outer blister and with cover foil.The sample shows no macroscopic signs of damage.The sample was functionally tested with other device.A disposable forceps was used as an essay.The surgical laser recognized the device.During the investigation, the sample was tested with the foot switch and also with different programs.The device was fully functional.The customer's complaint was not confirmed.A root cause for the customers reported event could not be determined because the returned product met manufacturer¿s specifications; it is not likely that a product malfunction could have contributed to the reported event.No action was taken as the returned sample met specifications for tests performed in relation to the reported event.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 PNEUMATIC HANDPIECE DSP
• Type of Device: UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE
• 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: 16437348
• MDR Text Key: 310276171
• Report Number: 3003398873-2023-00029
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 07612717071391
• UDI-Public: 07612717071391
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063583
• 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,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 725.03
• Device Lot Number: 14EFWX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1