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

Catalog Number	727.44
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during vitrectomy surgery, the tip of an ophthalmic forceps became loose and detached.The surgery was completed on the same day using another forceps and with no patient harm.
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).
Additional Manufacturer Narrative
Additional information is provided in sections: d.9, h.3, h.6 & h.11.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.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 additional complaint associated with it.The investigation is completed based on the sample evaluation documented below.The returned product was received in a carton box without using the original packaging material, specifically the inner and outer blister, which offers protection to the instrument during shipment, was not used.In the carton box was a plastic bag containing the instrument.The instrument shows macroscopic sing of damage, namely the cover sleeve and the guide sleeve are broken apart, as well the tip is loose.The sample exhibits no surgery residues.The instrument was visually inspected with the aid of a photomicroscope using various magnifications, which shows the damage in detail.However, the point in time when the noticed damage occurred can no longer be determined conclusively, nor can the strain put on the device be reconstructed.The customer¿s complaint is confirmed as the returned device shows significant damage, but a root cause for the reported issue cannot be determined.No root cause for the customer's reported event could be determined, since the situation that lead to the instrument failure cannot be reconstructed.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 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: 20912028
• Report Number: 3003398873-2024-00137
• Device Sequence Number: 7845940
• Product Code: HNR
• UDI-Device Identifier: 07612717071353
• UDI-Public: (01)07612717071353(17)260228(11)230314(10)15EE0D
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/06/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 727.44
• Device Lot Number: 15EE0D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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