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

Catalog Number	705.52P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that an ophthalmic scissors noted faulty and not closing during a vitrectomy procedure.The procedure was completed by using a different 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
Corrected information is provided in section h.6.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
No lot number was identified with this complaint.Therefore, the manufacturing documentation was not reviewed.All product and batch history records are quality reviewed, prior to product release.The sample is received with inner blister, outer blister and without cover foil.The sample shows no macroscopic signs of damage.The sample shows no signs of surgery residues.And is returned in a opened status.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The sample was functionally tested.It was noticed, that the scissors get stuck in a closed status.The scissors only can get open again by pushing the shaft manually down.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.The customers complaint is confirmed.It cannot be determined, how or where the damage to the sample occurred.Therefore, a root cause for the customers reported event could not be determined.However, the damage was consistent with damage that can occur, due to improper handling.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: 15353584
• Report Number: 3003398873-2022-00071
• Device Sequence Number: 20334300
• Product Code: HNF
• UDI-Device Identifier: 07612717070691
• UDI-Public: 07612717070691
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2023

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: ASKU
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 12/22/2022; 02/02/2023
• Initial Report FDA Received Date: 09/03/2022
• Supplement Report FDA Received Date: 01/17/2023; 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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