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

Catalog Number	705.52P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that an ophthalmic scissor was unable to open after use.Procedure details and patient impact were not provided.
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
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 relevant deviation and that there are no other complaints associated with the production lot.The investigation is closed based on the sample evaluation outlined below.The sample was received in its inner and outer blister and with the cover foil, showing the lot information.The sample shows no macroscopic signs of damage and no signs of surgery residues.The instrument was returned in an open state.One scissor blade broke off during the process of preparing the instrument for cleaning due to a mishap in the prodcut handling.Therefore, the sample evaluation could not be performed completely.However, the functional testing showed that the sleeve-tube connection was not broken and the actuation mechanism was in working condition after the damage to the sample.Due to the damage caused during the sample evaluation process, the reported issue could not be confirmed and no root cause could be identified.The performed assessments did not confirm a product issue.Since the sample evaluation could not be concluded, the root cause code "unable to verify" is selected.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 REVOLUTION DSP SCISSORS
• 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: 19457199
• Report Number: 3003398873-2024-00055
• Device Sequence Number: 6652923
• Product Code: HNF
• UDI-Device Identifier: 07612717070691
• UDI-Public: (01)07612717070691(17)240630(11)210716(10)140R3X(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2024

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 Catalogue Number: 705.52P
• Device Lot Number: 140R3X
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 10/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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