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

Catalog Number	705.52P
Medical Device Problem Codes	Break (1069); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample has been received at manufacturing for evaluation.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 before a surgery, an ophthalmic scissor was not going through canula and another scissor was not working well to cut.There was no patient involvement.Additional information has been requested.Additional information received indicated the event occurred before a vitreo-retinal surgery.The surgery was completed by using an another products.There was no impact to the patient.
Additional Manufacturer Narrative
Additional information is provided in sections h.6 and h.10.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.No sample received.Provided pictures were reviewed but are not enough to confirm this issue or identify a root cause.A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation.The sample is not available for investigation, therefore, damage cannot be confirmed or rather a root cause cannot be identified.Should sample return this complaint will be reopened and the sample will be investigated.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).
Additional Manufacturer Narrative
The sample has been received and in-house evaluation is in progress.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received indicated the ophthalmic scissor was broken.
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Provided pictures were reviewed but are not enough to confirm this issue or identify a root cause.The sample shows signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The customer¿s complaint was confirmed.It was found that the curved scissors can pass through the canula.The curved scissors cannot cut because of the missing cutting edge.The cutting edges are broken.When the cutting edge broke can no longer be determined.A root cause cannot be ascertained because the point in time, when the damage occurred can no longer be determined.The exact root cause for the customers reported event is unknown; therefore, specific action cannot be taken.The point in time when the cutting edge broke can no longer be determined.This complaint has been reviewed and future data will be monitored for evidence of adverse trending of reported events and further action will be taken, as appropriate.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: 12680617
• Report Number: 3003398873-2021-00079
• Device Sequence Number: 4012594
• Product Code: HNF
• UDI-Device Identifier: 07612717070691
• UDI-Public: 07612717070691
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/28/2022

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: 01/31/2023
• Device Catalogue Number: 705.52P
• Device Lot Number: F186691
• 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: 09/26/2021
• Supplement Date Received by Manufacturer: 12/21/2021; 04/29/2022; 06/03/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/27/2021; 05/23/2022; 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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