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

Catalog Number	706.52
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
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 physician reported that during surgery, an ophthalmic scissor broken.The procedure was completed using another new device.There was no patient impact reported.
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number 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 complaints associated it.The concerned sample was not sent to 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 investigation site.Therefore, the root cause for the customer complaint issue cannot be determined conclusively.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 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 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 complaints associated it.The investigation is completed based on the sample evaluation documented below.The returned instrument was received in its inner and outer blister, covered with the tyvek lid foil showing the lot information.The instrument shows obvious macroscopic signs of damage.Specifically, one scissor blade is broken off.The second scissor blade is deformed and bent to the side.The broken off scissor blade was not part of the delivery.The returned product exhibits some redish/orange foreign material or residues on the tip.The scissors was visually inspected with the aid of a photomicroscope using various magnifications.The fractured surface on the stub does not show any abnormalities that would indicate a root cause for the breakage.The visual inspection also showed that some of the foreign material could not be washed off by the established cleaning procedure.The provenance of the material could not be identified.As the blister was opened by the customer, the product was handled.This is confirmed by the intact scissor blade being bent to the side.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.It cannot be determined how or where the damage to the sample occurred.Therefore, the root cause for the customer's reported event could not 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).

• 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: 19709276
• Report Number: 3003398873-2024-00074
• Device Sequence Number: 6851141
• Product Code: HNF
• UDI-Device Identifier: 07612717066885
• UDI-Public: (01)07612717066885(17)251231(11)230102(10)158KLP(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 01/15/2025

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: 12/31/2025
• Device Catalogue Number: 706.52
• Device Lot Number: 158KLP
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 12/23/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 10/09/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LASER PROBES.
• Patient Sex: Unknown