MAUDE Adverse Event Report: ALCON GRIESHABER AG FINESSE REFLEX DSP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	811.13
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that ophthalmic forceps were poorly engaged during the vitrectomy surgery.The surgery was completed on the same day after replacing the product.Thee was no report of patient impact.
Additional 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 is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The initial decision to report was incorrect resulting in the initial report being submitted in error as the event forceps were poorly engaged was about the grasping issue not against the closing/opening of ophthalmic forceps which does not meet the criteria of reporting.Hence, the reports will be submitted under the manufacturer reference number 3003398873-2024-00072.The manufacturer internal reference number is: (b)(4).

• Brand Name: FINESSE REFLEX DSP FORCEPS
• Common Device Name: FORCEPS, 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: 19709225
• Report Number: 3003398873-2024-00072
• Device Sequence Number: 14237122
• Product Code: HNR
• UDI-Device Identifier: 07612717071575
• UDI-Public: 07612717071575
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 811.13
• Device Lot Number: 147EU9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/25/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown