MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER PNEUMATIC HANDPIECE DSP; UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE

Catalog Number	725.03
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
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 before a vitrectomy an ophthalmic handpiece had recognition failure before insertion.The surgery was performed and completed after replacing the product with another one.There was no patient harm was reported.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER PNEUMATIC HANDPIECE DSP
• Common Device Name: UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE
• 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: 16483711
• Report Number: 3003398873-2023-00031
• Device Sequence Number: 20311292
• Product Code: HQC
• UDI-Device Identifier: 07612717071391
• UDI-Public: 07612717071391
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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: 02/28/2025
• Device Catalogue Number: 725.03
• Device Lot Number: 14DD22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/15/2023
• Date Device Manufactured: 03/18/2022
• 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
• Patient Sex: Unknown