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

Catalog Number	705.52P
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the tip of two scissors detached during a vitreo-retinal surgery.There was no report of any patient harm.Additional information has been requested.Additional information has been received clarifying that the procedure was completed successfully without using the scissors.There was no patient harm.
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
No sample was received for evaluation.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.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
Two samples received without original packaging and without cover foil.One sample is deformed and shows one scissor blade.The other not deformed sample shows no scissors blades.One of the instruments showed a very strong bent cannula.At the time of investigation both instruments missed both scissor blades although one of the instruments still had one scissor blade fixed at the time of receiving.This missing blade was most possible broken off during cleaning as the device was already in very bad condition and not well protected during sending to the manufacturing site.Since in this case both blades were broken off a destructive investigation was performed.The scissor insert was removed from the instrument and investigated.No further signs were found indicating the cause of the fracture.A 100% functional test is performed during production, which ensures that the instrument fulfills the specification before it will be delivered.The cause of the fracture cannot be determined anymore.The root cause was unable to be verified as no signs were found indicating the cause of the fracture.A manufacturing or design related root cause for the damage of the complained device has not been identified.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: 12894345
• Report Number: 3003398873-2021-00091
• Device Sequence Number: 3644030
• Product Code: HNF
• UDI-Device Identifier: 07612717070691
• UDI-Public: 07612717070691
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/07/2022

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: 12/31/2021
• Device Catalogue Number: 705.52P
• Device Lot Number: F173251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 12/02/2021; 01/13/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/28/2021; 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2019
• 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