MAUDE Adverse Event Report: ALCON GRIESHABER AG SUTHERLAND HANDLE NG; SCISSORS, OPHTHALMIC

Catalog Number	712.00.11
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
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 before epiretinal membrane surgery an ophthalmic handle was rusted could not be used.Surgery was completed with an alternative handle and with no patient harm.
Additional Manufacturer Narrative
A manufacturing device history record (dhr) review was performed to ensure that the product was manufactured in compliance with the device master record.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 one additional complaint regarding the same which was filed by the same reporting entity.The concerned sample was not received at the investigation site for evaluation.Therefore, no further assessment is possible and the investigation is concluded without identifying the root cause.A sample was not received at the manufacturing site.Therefore, the root cause for the customer complaint issue 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).
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.A manufacturing device history record (dhr) review was performed to ensure that the product was manufactured in compliance with the device master record.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 one additional complaint regarding the same which was filed by the same reporting entity.The investigation is completed based on the evaluation of the returned sample illustrated below.The shipment associated with this complaint included three sutherland handles as indicated above.The handles came in their original packaging.For all three returned instruments, the security seal and the stick-on label where still intact, indicating that the product was not opened by the customer.It could be seen too that the instrument were not unpackaged yet.All three instruments were unpackaged for investigation and subjected to a rigorous visual inspection regarding any signs of rust/corrosion.However, no rust could be identified and the products were found to be in working condition.Therefore, the returned instruments meet specifications and the reported event could not be confirmed.The returned product met manufacturer¿s specifications and the customer's complaint is not confirmed.No action was taken as the returned sample met specifications for tests performed in relation to the reported event.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: SUTHERLAND HANDLE NG
• Common Device Name: SCISSORS, 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: 19642557
• Report Number: 3003398873-2024-00069
• Device Sequence Number: 12551827
• Product Code: HNF
• UDI-Device Identifier: 07612717062238
• UDI-Public: (01)07612717062238(17)300125(11)200225(10)F197416(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): 11/19/2024

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: 712.00.11
• Device Lot Number: F197416
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 08/30/2024; 10/24/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/27/2024; 11/19/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown