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

Catalog Number	705.52P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
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 customer reported that during posterior vitrectomy, an ophthalmic forceps clamp did not open and stuck.The surgery was completed on the same day.There was no patient harm.
Additional Manufacturer Narrative
Additional information is provided in sections d.4, h.6 and h.11.A review of the device history record traceable to the reported lot number indicates that the reported product was processed and released according to the reported 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 deviation and that there are no additional complaints associated with it.The complainant provided videos which show the reported event.In these videos, it can be seen that the revolution disposable (dsp) instrument is being activated and released yet the scissor blades remain closed.It can also be seen that this is due to tube not moving with the plastic tip of the handle.This indicates that the sleeve-tube bonding connection is broken.The concerned product was not provided to the investigation site for evaluation.Therefore, no further assessment is possible and the investigation is concluded without identifying the root cause.The concerned product was not provided to the investigation site.Therefore, the root cause for the customer complaint cannot be determined conclusively.The exact root cause for the customer's reported event is unknown, therefore, specific action cannot be taken.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: 20339944
• Report Number: 3003398873-2024-00113
• Device Sequence Number: 7879872
• Product Code: HNF
• UDI-Device Identifier: 07612717070691
• UDI-Public: (01)07612717070691(17)260731(11)230830(10)164LXX(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 705.52P
• Device Lot Number: 164LXX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/31/2024
• Date Device Manufactured: 08/30/2023
• 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