MAUDE Adverse Event Report: ALCON GRIESHABER AG DIATHERMY PROBE DSP; UNIT, PHACOFRAGMENTATION, ACCESSORY, PROBE

Catalog Number	339.31
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
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 during vitrectomy surgery an ophthalmic diathermy probe could not electrocoagulate.The surgery was completed after a new replacement was used.No patient harm was reported.
Additional Manufacturer Narrative
Additional information is provided in sections h.6 and h.11.The provided image shows the tyvek pouch of the reported article.The associated article itself is not shown, which is why the image does not support the investigation.The associated article itself was not received at the investigation site.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 non-conformance based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.The product was not received at the manufacturing site.Therefore, the root cause for the customer's complaint could not be identified.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.The manufacturer internal reference number is: (b)(4).

• Brand Name: DIATHERMY PROBE DSP
• Common Device Name: UNIT, PHACOFRAGMENTATION, ACCESSORY, PROBE
• 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: 21948433
• Report Number: 3003398873-2025-00278
• Device Sequence Number: 18322985
• Product Code: HQC
• UDI-Device Identifier: 07612717071384
• UDI-Public: (01)07612717071384(17)270228(11)240308(10)16LLLT
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 339.31
• Device Lot Number: 16LLLT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 08/13/2025
• Date Device Manufactured: 03/08/2024
• 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