MAUDE Adverse Event Report: ALCON GRIESHABER AG FINESSE REFLEX DSP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	805.88
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample has been received by manufacturing that has not yet been evaluated.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during combined cataract/vitrectomy procedure forceps became impossible to open and close.The surgery was completed after replacing the product with another one.There's no patient harm.
Additional Manufacturer Narrative
The sample was received with inner blister, outer blister and without cover foil.The blister in which the sample had been received are not from this device.The sample has a lot of space inside.The sample showed no macroscopic signs of damage.The sample showed no signs of surgery residues and was returned in a closed status.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The sample was functionally tested.It was noticed that is not possible to open the forceps.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 customer¿s complaint was confirmed.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.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.The exact root cause for the customer¿s reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: FINESSE REFLEX DSP FORCEPS
• Common Device Name: FORCEPS, 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: 15110813
• Report Number: 3003398873-2022-00049
• Device Sequence Number: 19870953
• Product Code: HNR
• UDI-Device Identifier: 07612717071711
• UDI-Public: 07612717071711
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/02/2022

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 Catalogue Number: 805.88
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 10/02/2022
• 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