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

Catalog Number 339.21

Device Problem Insufficient Heating (1287)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/19/2023

Event Type  Injury  

Event Description

The government agency reported that patient experienced retinal hemorrhage during the surgery.An ophthalmic probe was used to give electrocoagulation to stop the bleeding but it did not work.The current outcome of the patient was unknown and surgery was completed in the same ay by using the alternative product.

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).

Manufacturer Narrative

No lot number was identified with this complaint, therefore the manufacturing documentation was not reviewed.All product and batch history records are quality reviewed prior to product release.No sample was expected to be returned to the investigation site for evaluation.With the provided information, no further assessment is possible and the investigation is concluded.A sample was not received at the manufacturing site therefore, the root cause for the customer complaint regarding the probe not working could not be determined.The retinal bleeding occurred during surgery but is unrelated to the device.It can be considered a pre-existing condition as the occurrence of the bleeding required the use of the concerned product (probe for coagulation and therefore stopping of the bleeding) in the first place.The exact root cause for the customers reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.

• 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: 18082693
• MDR Text Key: 327475454
• Report Number: 3003398873-2023-00213
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 07612717071377
• UDI-Public: 07612717071377
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/21/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male