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

Catalog Number	706.44
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
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 healthcare professional reported that jaws of an ophthalmic surgical forceps do not open properly for use during surgery.The surgery was completed on the same day after replacing with another new forceps.No patient impact was reported.
Additional 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.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 is no additional complaint associated with it other than the ones from this report.The investigation was concluded based on the sample evaluation outlined below.The sample was received at the investigation site in its inner and outer blister and covered with the tyvek lid foil showing the lot information.The sample does not show macroscopic signs of damage and is returned in an open state.There is some traces of surgery residues.The sample was visually inspected with the aid of a photomicroscope using various magnifications and was functionally tested.It was found during the inspection that the actuation mechanism works as intended.When actuating the mechanism, the forceps opens and closes without an increased amount of friction or any blocking.The opening of the grasping arms was then tested with the relevant inspection equipment and it was found that the opening of the forceps is too small.As the blister was opened by the customer, the product was handled.Therefore, it is not possible to determine what situation could have caused the malfunction and no root cause can be identified conclusively from the sample evaluation.Since the situation that lead to the issue can not be reconstructed, a root cause for the customer's reported event could not be determined conclusively.However, potential contributing factors were identified on a previous complaint regarding a comparable defect and are currently being investigated in the framework of a record.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 REVOLUTION 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: 19944032
• Report Number: 3003398873-2024-00084
• Device Sequence Number: 4890749
• Product Code: HNR
• UDI-Device Identifier: 07612717066960
• UDI-Public: (01)07612717066960(17)260531(11)230608(10)15TL42(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 706.44
• Device Lot Number: 15TL42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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 Sex: Unknown