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

Catalog Number	725.44
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot number was identified with this complaint, therefore the manufacturing documentation was not reviewed.However, all product and batch history records are quality reviewed prior to product release.A non-conformance review and complaint history review could not be performed due to missing lot number.The sample was received in its inner blister and put into a zip-lock bag.The outer blister or the tyvek lid (which would show the batch information) were not used.The sample shows no macroscopic signs of damage and is returned in an open state.The sample shows no signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope using various magnifications, which showed no abnormalities.It was then functionally tested, where the actuation of the instrument was still functioning as expected and without blocking the instrument.However, it was also noticed that the shaft can manually be pushed down and pulled up from the plastic tip, indicating that the bonding connection between the metal shaft and the plastic tip got broken.This confirms the customer¿s complaint.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 root cause of the issue could therefore not be identified conclusively.No root cause for the customer's reported event could be determined since the situation that led to the described issue could not be reconstructed.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).
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 membrane peel pas plana vitrectomy procedure, an ophthalmic forceps shaft was loose and tip would not engage.Forceps was stuck in full open position.Surgery was completed with new forceps on the same day with no patient harm.

• 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: 19517688
• Report Number: 3003398873-2024-00057
• Device Sequence Number: 6030714
• Product Code: HNR
• UDI-Device Identifier: 07612717071001
• UDI-Public: 07612717071001
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2024

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 Catalogue Number: 725.44
• Device Lot Number: ASKU
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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