MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER MAXGRIP ADVANCED DSP TIP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	725.13P
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that ophthalmic forceps exhibited difficulty in opening and closing, along with an issue of attaching it to the handle.The surgery was completed the same day using a replacement forceps.Information regarding the affected eye and patient identifier is unavailable.No patient harm occurred.Additional details have been requested but have not been received till date.
Additional Manufacturer Narrative
The returned instrument was received at the manufacturing site in its inner and outer blister, covered with they tyvek lid foil showing the batch information.The returned instrument shows no macroscopic signs of damage.The returned instrument was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection showed no immediate issues with the product such as burrs, bending of grasping arms or misalignment.No breakage is evident either.Upon functionally testing the instrument, when actuated, resistance is noticeable.The situation in which the malfunction occurred can no longer be reconstructed, nor can the strain put on the device be determined.Therefore, the customer¿s complaint is confirmed, but the root cause cannot be identified by this investigation.A review of the device history record traceable to the reported lot numbers, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.Non-conformance report provided by originator.A non-conformance-based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint it cannot be determined how or where the damage to the sample occurred.Therefore, the root cause for the customer's reported event could not be determined.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER MAXGRIP ADVANCED DSP TIP 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: 22866535
• Report Number: 3003398873-2025-00356
• Device Sequence Number: 20766488
• Product Code: HNR
• UDI-Device Identifier: 07612717071155
• UDI-Public: (01)07612717071155(17)271031(11)241105(10)174LLW
• 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
• Report Date (Section B): 08/21/2025

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 Catalogue Number: 725.13P
• Device Lot Number: 174LLW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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