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

Catalog Number	705.52P
Medical Device Problem Codes	Fitting Problem (2183); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during surgery the tip of the blade stopped closing during insertion and could not be pulled out of the trocar while using the scissors.Surgery was completed after replacing the product with another one.No patient impact was reported.
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
Corrected information is provided in d.4 and h.11.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 customer reported that the tip of a 25+ revolution dsp curved scissors stopped closing.A review of the device history record traceable to the reported lot numbers, 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 with it.The investigation is completed based on the sample evaluation outlined below.The returned instrument was received in its inner blister, covered with the tyvek lid foil showing the lot information.As described in the initial report description, the trocar cannula was still on the metal tube of the returned instrument.The product¿s actuation mechanism shows some deformed levers on the basket, but no other macroscopic signs of damage are evident.There are no clear signs of surgery residues.The scissors was provided in an open state.The scissors was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection showed that the scissor blades are opened too widely since they do not show any overlap.The scissors was then functionally tested and it was noticed that the actuation mechanism is still in working condition but the scissors cannot be closed anymore.It was found that the scissors insert sits loosely and can be pulled away from the actuation handle by about a millimeter before it got stuck again.This finding indicates the connection between the scissors insert and the actuation mechanism got broken.During investigation, one of the scissor blades got broken off and the breaking site could not be inspected.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.No root cause for the customer's reported event could be determined, since the situation that lead to the instrument failure cannot be reconstructed.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: 20382774
• Report Number: 3003398873-2024-00115
• Device Sequence Number: 8037830
• Product Code: HNF
• UDI-Device Identifier: 07612717070691
• UDI-Public: (01)07612717070691(17)270331(11)240430(10)16RR7P(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/06/2025

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 Catalogue Number: 705.52P
• Device Lot Number: 16RR7P
• 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: 09/08/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 12/09/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/05/2024; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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