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 04/15/2022

Event Type  Injury  

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 customer reported that during a surgery electrocoagulation head had no reaction and could not stop bleeding.The surgery was completed by changing the new electrocoagulation head.

Manufacturer Narrative

Corrected information is provided in sections h.1 and b.2.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Sample was not received by the investigation site for evaluation.The root cause cannot be identified conclusively because no picture or sample has been received.Investigation has been completed based on current information.Should sample returned, this file will be re-opened and failure analysis will be performed.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: 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: 14391514
• MDR Text Key: 291823621
• Report Number: 3003398873-2022-00031
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 339.21
• Device Lot Number: 140T0P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 05/12/2022; 07/13/2022
• Supplement Dates FDA Received: 05/27/2022; 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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: 4 YR
• Patient Sex: Female