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

Catalog Number	339.31
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is in transit to the manufacturing site and has not yet been evaluated.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 a diathermy probe could not cauterize the eye tissue during a cataract/vitrectomy combination procedure.The surgery was completed after replacing the product with another one.The involved eye and the patient identifier are not available.There was no patient harm.
Additional Manufacturer Narrative
Sample received in opened original packaging with cover foil.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.No abnormality was observed.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.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 root cause was unable to be verified as no signs were found indicating the cause of insufficient contact.A manufacturing or design related root cause for the damage of the complained device has not been identified.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.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
• MDR Report Key: 12165527
• Report Number: 3003398873-2021-00046
• Device Sequence Number: 4052256
• Product Code: HQC
• UDI-Device Identifier: 07612717071384
• UDI-Public: 07612717071384
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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 Expiration Date: 09/30/2021
• Device Catalogue Number: 339.31
• Device Lot Number: F169994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1