MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR SIGNATURE, ACP; FOOTPEDAL ACCESSORY

Model Number	NGP680702
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	Vitrectomy (2643)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Phone: (b)(6).The system was evaluated by a field service engineer (fse).The fse replaced the rear panel connector printed circuit board, the wireless fp receiver and the footpedal accessory.A field service checklist was performed.The unit complied with all factory settings.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract extraction procedure, the surgery center reported a short interruption resulting in a vitrectomy surgical procedure.It was reported that phaco machine had unexpected continuous irrigation.After the vitrectomy was performed the cataract surgery was finished successfully and the patient¿s outcome is good.The surgery center did not suspect the j&j system caused the vitrectomy to occur.No further information provided.This report is for the footpedal accessory.A separate report will be submitted for the phacofragmentation unit.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: WHITESTAR SIGNATURE, ACP
• Common Device Name: FOOTPEDAL ACCESSORY
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8930461
• Report Number: 3006695864-2019-00690
• Device Sequence Number: 19365254
• Product Code: HQC
• UDI-Device Identifier: 05050474534667
• UDI-Public: (01)05050474534667
• Combination Product (Y/N): Y
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NGP680702
• Device Catalogue Number: NGP680702
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHACOFRAGMENTATION UNIT SN (B)(6); PHACOFRAGMENTATION UNIT SN (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005