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

Catalog Number	725.13P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The physician reported that during vitrectomy surgery the gripping section of an ophthalmic forceps was poor, and when the target membrane was gripped, the gripping section edge broke off and could not be used during insertion.The surgery was completed without any patient harm after replacing the product with another one.The patient identifier were not available.
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
The initial decision to report was incorrect resulting in the initial report being submitted in error.This event gripping section edge broke off and could not be used during insertion is not considered to be a reportable malfunction and its is not likely that a recurrence would result in serious injury.No further reports will be submitted under mfg report num.3003398873-2025-00009.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: 21167280
• Report Number: 3003398873-2025-00009
• Device Sequence Number: 4603763
• Product Code: HNR
• UDI-Device Identifier: 07612717071155
• UDI-Public: (01)07612717071155(17)270228(11)240325(10)16N9XD
• 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): 04/04/2025

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: 16N9XD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/04/2025
• Date Device Manufactured: 03/25/2024
• 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