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

Catalog Number	706.52
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a surgery an ophthalmic micro scissor was unable to close and one of the blades fell out onto the surgical field.The surgery was completed using another scissor.There was no harm to the patient.
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.The sample was received with inner blister and with cover foil.The inner blister is not from this device.The sample shows macroscopic signs of damage.It is visible that one scissor is missing.The samples shows signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The customers complaint are confirmed.During the visually inspection it was noticed that one scissor is missing.The point in time when the malfunction occurred, can no longer be determent.The root cause cannot be identified conclusively because the sample has pass the 100% inspection.As the blister was opened by the customer, he handled the product.The point in time when the malfunction occurred, can no longer be determent.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.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: 13962595
• Report Number: 3003398873-2022-00014
• Device Sequence Number: 19901490
• Product Code: HNF
• UDI-Device Identifier: 07612717066885
• UDI-Public: 07612717066885
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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: 12/31/2023
• Device Catalogue Number: 706.52
• Device Lot Number: 13RJC1
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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 Sex: Unknown