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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2022

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 an diathermy probe did not work.The surgery was completed with no reports of patient ham.

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.The instrument was visually inspected.It was noticed, that the shaft was bent.Electrical resistance measurements, indicate insufficient contact.When the instrument was opened, the contacts were not destroyed.Nevertheless, no defect contact points in the instrument could be identified.All contact points were specifically investigated, but non of the contact points was loose.Based on the outcome of this investigation, the complaint of the customer can be confirmed, but the root cause could not be determined anymore.The most likely root cause could be that the device is bent.In production a 100% inspection of the instrument is performed, which would identify defect contact points.Since the instrument passed this test, the contact must have been affected later.But, this cannot be determined anymore.The customers complaint is confirmed.The root cause cannot be identified conclusively, because the sample has pass the 100% inspection.As the blister was opened by the customer, he handled the product.The point in time when the malfunction occurred, can no longer be determent.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.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: 15876295
• MDR Text Key: 305507173
• Report Number: 3003398873-2022-00100
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 339.21
• Device Lot Number: F191058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1