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

Catalog Number	725.44P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
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 during vitrectomy surgery, an ophthalmic forceps could not be opened.The procedure was completed, and no patient impact was reported.
Additional Manufacturer Narrative
Corrected information was provided in d.4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in sections d.9, h.3 h.6 and h.11.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.The investigation is concluded based on the sample evaluation outlined below.The returned instrument was received at the investigation site in its inner and outer blister and covered with the tyvek lid foil showing the lot information.The instrument does not show macroscopic signs of damage and is returned in an open state.There are no signs 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 forceps gets stuck in a closed position, while the actuation mechanism itself is still in working condition.The forceps can only get opened again by manually pushing down the metal shaft, indicating that the bonding connection between the shaft and stiffening sleeve got broken.The bonding site was then inspected visually, which showed that the adhesive is mostly located on one side of the tube and that there are no signs of it being distributed around the tube by applying a circular motion when pulling the sleeve over it.As the blister was opened by the customer, the product was handled.Therefore, the point in time when the malfunction occurred can no longer be determined, nor can the strain put on the device be reconstructed.The customer¿s complaint is confirmed, but a root cause for the connection failure cannot be determined conclusively.However, the investigation continued in a non-conformance investigation to determine whether or not the uneven distribution of the adhesive might have contributed to the break of the bonding site.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 by the inspection of the returned product's bonding site and are currently being investigated in the framework of a capa record.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: 20029744
• Report Number: 3003398873-2024-00091
• Device Sequence Number: 8591151
• Product Code: HNR
• UDI-Device Identifier: 07612717071018
• UDI-Public: (01)07612717071018(17)260731(11)230829(10)164JAE(21)NA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2024

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: 07/31/2026
• Device Catalogue Number: 725.44P
• Device Lot Number: 164JAE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 12/05/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/16/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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