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

Catalog Number	705.52
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
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.A sample is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that an ophthalmic blade was broken during surgery.Details of procedure and patient harm was not reported.Additional details has been requested and none received till date.Additional information received reporting that during vitrectomy surgery the knife was broken.The surgery was completed on the same day with alternative product.There was no patient harm.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.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 deviation and that there are no additional complaints associated with it.The investigation is concluded based on the sample evaluation outlined below.The sample was received in its outer blister and with the cover foil showing the batch information.The inner blister, which offers protection to the instrument during shipment, was not used.The sample evidently shows macroscopic signs of damage, namely that both of the scissor blades are broken off.One of the scissor blades was stuck to the blister with a tape.The second blade was originally loosely in the blister and got caught by a tape used to fix the tyvek foil in place.Supported by the initial report, it is therefore assumed that only one of the blades was broken during use and the second blade got broken off during the shipment from the complainant to the investigation site.The sample was visually inspected with the aid of a photomicroscope under various magnifications.The fractured surfaces were assessed and do not show any abnormalities that would indicate a root cause for the breakage.As the blister was opened by the customer and per the initial report description, the product was handled and used on a patient.The situation in which the malfunction occurred can no longer be determined, nor can the strain put on the device be reconstructed.The customer¿s complaint is therefore confirmed but the root cause cannot be conclusively identified by this investigation.It cannot be determined how or where the damage to the sample occurred.Therefore, a root cause for the customer's reported event could not be determined conclusively.The exact root cause for the customer's reported event is unknown, therefore, specific action cannot be taken.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: 18977146
• Report Number: 3003398873-2024-00028
• Device Sequence Number: 17712065
• Product Code: HNF
• UDI-Device Identifier: 07612717064638
• UDI-Public: (01)07612717064638(17)240331(11)210408(10)13UYYT(21)NA
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 705.52
• Device Lot Number: 13UYYT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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 Age: 5 YR
• Patient Sex: Male