MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER MAXGRIP ADVANCED DSP TIP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	727.13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A nurse reported that one of forceps broke off and fell into patient's eye and retrieved during the surgery.The surgery was completed after replacing the product with another one.The involved eye and the patient identifier are not available.There was no patient harm.The procedure type was an unknown.
Additional Manufacturer Narrative
The investigation is completed.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.A design change was initiated to improve the reliability of the device.The sample received with outer blister and cover foil, but without inner blister.The sample shows macroscopic signs of damage.One arm of the forceps is broken.The sample shows no signs of surgery residues.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The sample was visually inspected.It was noticed that one arm of the forceps is broken.As the blister was opened by the customer, he handled the product.The point in time when the malfunction occurred, can no longer be determined.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 exact root cause for the customers 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: GRIESHABER MAXGRIP ADVANCED DSP TIP 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: 17116563
• Report Number: 3003398873-2023-00065
• Device Sequence Number: 6611670
• Product Code: HNR
• UDI-Device Identifier: 07612717071339
• UDI-Public: 07612717071339
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 727.13
• Device Lot Number: 153U27
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown