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

Catalog Number	725.13P
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
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 physician reported that during vitrectomy surgery membrane could not be grasped during insertion due to opening/closing failure of the forceps tip.The surgery was completed with alternative product.There was no patient harm.
Additional Manufacturer Narrative
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 review of the database for the non-conformance events and the complaints showed that the given lot number was not concerned by any relevant deviation and that no other entity reported complaints on the given production lot.The investigation is concluded based on the sample evaluation outlined below.The returned instrument was received in its inner blister covered with the tyvek lid foil.The lid foil shows the lot information.The instrument showed no macroscopic signs of damage but exhibited surgery residues.It is returned in an open state.The returned instrument was visually inspected with the aid of a photomicroscope using various magnifications.During the visual inspection, no abnormalities could be identified.The forceps arms of the instrument opened and closed as expected and the grasping arms showed no bending and no misalignment was found.No burrs or rough edges were present on the returned instrument.The instrument was then functionally tested and appeared to be working normally.Specifically, it was noticed that the instrument was able to grasp and hold the corresponding control weight, which indicates that the grasping force of the device fulfills its acceptance criteria.Therefore, the customer¿s complaint could not be confirmed.A root cause for the customer's reported event could not be determined because the returned product met manufacturer¿s specifications.No action was taken as the returned sample met specifications for tests performed in relation to the 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: 20274991
• Report Number: 3003398873-2024-00108
• Device Sequence Number: 3469681
• Product Code: HNR
• UDI-Device Identifier: 07612717071155
• UDI-Public: (01)07612717071155(17)261130(11)231218(10)16E1PK(21)NA
• 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): 11/26/2024

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: 725.13P
• Device Lot Number: 16E1PK
• 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: 08/25/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 09/21/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM
• Patient Sex: Unknown