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

Catalog Number	705.44
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
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 health professional reported that while performing vitreoretinal surgery, an ophthalmic forceps became stuck in the closed position while inside of the patient¿s eye.The reported forceps was successfully removed from the patient¿s eye and an alternate forceps was used to complete the procedure.There was no harm to the patient.
Additional Manufacturer Narrative
Sample received without original packaging and without cover foil.Sample show surgery residuals.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.All product and batch history records are quality reviewed prior to product release.The sample was visually inspected with the aid of a photomicroscope and with various magnifications.It was found that the shaft is very bent.The forceps shows surgery residuals.Due to the condition of the sample the customer's complaint could not been confirmed.The bending does not allow a detailed examination of the root cause.The root cause for the reported event could not be determined conclusively due to insufficient sample.A manufacturing or design related root cause for the damage of the complained device has not been identified.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER REVOLUTION DSP 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: 12777871
• Report Number: 3003398873-2021-00082
• Device Sequence Number: 11189248
• Product Code: HNR
• UDI-Device Identifier: 07612717064263
• UDI-Public: 07612717064263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

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: 705.44
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male