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

Catalog Number	705.13P
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
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 customer reported that the tip of an ophthalmic forceps could not close during surgery.Surgery was completed after replacing a product with a new one.There was no patient harm.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in sections d.9, h.3, h.4,h.6 and h.11.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.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 are no additional complaints associated with it.The investigation is concluded based on the sample evaluation outlined below.The returned instrument was received at the investigation site in its outer blister, covered with the tyvek lid foil which shows the lot information.The inner blister which offers protection during the shipment was not used.The instrument evidently shows macroscopic sign of damage.Specifically, the forceps arms and the tube are significant bent.The returned instrument was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection confirmed the macroscopically noticeable damage and displayed the deformation of the forceps arms in detail.The level of damage as well as the missing inner blister suggest that the deformation of the forceps arms and the tube was caused during the shipping process from the complainant to the investigation site.As the blister was opened by the customer, the product was handled.Therefore, the point in time when the defect occurred can no longer be determined, nor can the strain put on the device be reconstructed.The customer's complaint is therefore confirmed but the root cause cannot be identified by this investigation.Since the situation that lead to the damage can not be reconstructed, a root cause for the product defect cannot be determined.The exact root cause for the customer's 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 MAXGRIP 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: 21750125
• Report Number: 3003398873-2025-00254
• Device Sequence Number: 20888064
• Product Code: HNR
• UDI-Device Identifier: 07612717070721
• UDI-Public: (01)07612717070721(17)270430(11)240517(10)16U0R2
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2025

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: 705.13P
• Device Lot Number: 16U0R2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 04/30/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/02/2025; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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 Age: 78 YR
• Patient Sex: Female