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	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available that has not yet been received at manufacturing for evaluation.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 a diathermy tip failed to coagulate during surgery.An alternate diathermy probe was obtained in order to complete the procedure.There was no patient harm.
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.Sample received, in opened original packaging with cover foil.An electrical conductibility measurement was performed.And recognized that the outer pole did not have appropriate contact.A visual inspection showed, a strongly deformed needle.Base on this investigation customer complaint is confirmed.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.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
• Common Device Name: 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: 12527230
• Report Number: 3003398873-2021-00072
• Device Sequence Number: 17141220
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: 07/31/2023
• Device Catalogue Number: 339.31
• Device Lot Number: F193237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown