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

Catalog Number	706.52
Medical Device Problem Code	Break (1069)
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 nurse reported that during vitrectomy surgery, an ophthalmic scissor tip break inside the patient eye.The surgery was completed.There was no patient impact reported.
Additional Manufacturer Narrative
No lot number was identified with this complaint, therefore the manufacturing documentation was not reviewed.However, all product and batch history records are quality reviewed prior to product release.Two images were sent by the originator and show the same scene in different magnifications.The images show a surgical table with a set of instruments used for eye surgery on a blue drape.One of the shown instruments is a scissors as indicated by the provided report description.It is evident from the picture, that one of the scissor blades was broken off, which confirms the reported event.The breaking site is not shown in additional details, therefore no further assessment can be made and the root cause for the break cannot be identified.The concerned products were not received at the investigation site for evaluation.Therefore, no further assessment is possible and the investigation is concluded without identifying the root cause.The concerned products were not received at the investigation site and not enough information was provided for further investigation.Therefore, the root cause for the customer complaint issue cannot be determined conclusively.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: 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: 20329254
• Report Number: 3003398873-2024-00112
• Device Sequence Number: 15423414
• Product Code: HNF
• UDI-Device Identifier: 07612717066885
• UDI-Public: 07612717066885
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 12/21/2024

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: 706.52
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 12/01/2024
• Initial Report FDA Received Date: 09/28/2024
• Supplement Report FDA Received Date: 12/21/2024
• 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