MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS 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	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone number: (b)(6).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 abbott medical optics has been submitted.
Event or Problem Description
The account reported that handpiece became too hot during tune and surgery.They checked with demo handpiece it was working fine.It was confirmed that there was no patient involvement for this event and no patient injury reported.No further information was provided.
Additional Manufacturer Narrative
The abbott medical optics (amo) field service specialist (fss) visited customer site and upon inspection of the customer's system and handpiece found the handpiece became hot intermediately.Fss replaced the handpiece with another one (serial no.(b)(4)).Fss checked the system with the new handpiece and found all parameters as per required specifications.Device evaluation: the labeling, trending and risk documentation reviews for this equipment were performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the received 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 device was reviewed and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for this device was also performed which showed that there were no issues or non-conformities and that the unit and its components met all specifications prior to being released.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): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6889458
• Report Number: 3006695864-2017-00791
• Device Sequence Number: 19010660
• Product Code: HQC
• UDI-Device Identifier: 05050474508040
• UDI-Public: (01)05050474508040
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1