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

Catalog Number 339.21

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2024

Event Type  malfunction  

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 Description

A physician reported that the ophthalmic diathermy probe failed to coagulate at the surgical site (eye unknown) during cataract vitrectomy combination surgery.It was also reported that footswitch and pak could not be used due to operating failure.The ultrasound and operation of the foot switch was also different from usual.The surgery was completed on the same day after replacing with another console and pak with no patient harm.

• Brand Name: DIATHERMY PROBE DSP
• Type of Device: 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: 19190076
• MDR Text Key: 341120577
• Report Number: 3003398873-2024-00043
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 07612717071377
• UDI-Public: 07612717071377
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 339.21
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1