MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR PHACO HANDPIECE (COAXIAL)

Model Number	690697
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer did not request for a field service specialist visit to the site and only an accessory exchange was requested.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The account reported that the handpiece would not tune and became too hot.There was no patient involvement for this event and no patient treatments delayed or cancelled.No further information was provided.
Additional Manufacturer Narrative
Correction: manufacturer date: 08/28/2017.Additional information: device available for evaluation? yes.Returned to manufacturer on: 07/12/2018.Device returned to manufacturer? yes.Device evaluation: the device was returned to the manufacturer.The handpiece was evaluated.The evaluation found the stack/ cable discoloration due to improper cleaning.There was evidence of moisture ingress and chemical exposure.The exposure would cause the discoloration and compromise the seal of the handpiece; leading to moisture ingress.The reported issue was confirmed, and the failure mode was due to improper cleaning and sterilization problem.A record review was performed.A product deficiency review was performed and there is no product deficiency identified.The risk management files and trending were reviewed.There is not a recognizable adverse trend.The risks and mitigation associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.No labeling change is required.The review of the device history record (dhr) for ellips whitestar phaco handpiece showed that there were no related issues or related non-conformities.Manufacturing has been ruled out as a potential cause for the reported issue.No conclusive evidence identified for reported issue.The handpiece is working within amo specifications.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: WHITESTAR PHACO HANDPIECE (COAXIAL)
• Common Device Name: PHACO HANDPIECE
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7561573
• Report Number: 3006695864-2018-01275
• Device Sequence Number: 1186524
• Product Code: HQC
• UDI-Device Identifier: 05050474508040
• UDI-Public: (01)05050474508040
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018
• Report Date (Section F): 01/01/2005

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: Physician
• Device Model Number: 690697
• Device Catalogue Number: 690697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005