MAUDE Adverse Event Report: ALCON GRIESHABER AG FINESSE SHARKSKIN ILM FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	705.88P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that ophthalmic forceps got stuck during surgery.The details of procedure and patient harm were not reported.Additional information has been requested and none received till date.Additional information received reporting that during vitrectomy surgery forceps got stuck.Procedure was completed with alternative product and there was no patient harm.
Additional Manufacturer Narrative
A review of the database for the non-conformance events and the complaints showed that the given lot number was not concerned by any deviation and that there are no further complaints associated with the given lot.The concerned sample was expected but not received by the investigation site for evaluation.Therefore, no further assessment is possible and the investigation is concluded without identifying the root cause.A sample was not received at the manufacturing site which is why the root cause for the customer complaint issue cannot 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: FINESSE SHARKSKIN ILM 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: 18729400
• Report Number: 3003398873-2024-00019
• Device Sequence Number: 7055708
• Product Code: HNR
• UDI-Device Identifier: 07612717071544
• UDI-Public: 07612717071544
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: 05/31/2026
• Device Catalogue Number: 705.88P
• Device Lot Number: 15VHH8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• 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 Age: 85 YR
• Patient Sex: Female