MAUDE Adverse Event Report: WELCH ALLYN INC. GS 777 WALL TRANSFORMER W/OPHTH & OTO UK; STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC

Model Number	77754
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the wall system's transformer plug adapter exploded causing a temporary power outage and damaged two leads.There was no adverse event reported.
Additional Manufacturer Narrative
The customer reported that they had an electrician visit the site where no fault was identified with the facilities electrical system.A device inspection is pending to determine a root cause of the reported incident.A final report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Correction to g3.Date received by manufacturer.The device was returned to the manufacturer for inspection.It was determined that the uk plug inside and outside and the housing of the power supply were black.The problem was concluded to be due to a defective power supply.The green series (gs) 777 wall system consists of a wall transformer and accessories that can be used with it.Gs 777 wall system the green series (gs) 777 wall transformer supplies power to two corded, handle-based rheostats.The customer can attach various otoscope and ophthalmoscope heads to the handles.The intensity of the light produced by the heads is controlled by twisting the rheostat.The product is connected to a 5-watt power supply via a usb 2.0 mini-b to twin usb cable.Although there was no adverse event reported and the root cause could not be confirmed, if the plug were to explode during use, it would be likely to cause or contribute to a death or serious injury if this were to recur.
Event or Problem Description
The customer reported that the wall system's transformer plug adapter exploded causing a temporary power outage and damaged two leads.There was no adverse event reported.

• Brand Name: GS 777 WALL TRANSFORMER W/OPHTH & OTO UK
• Common Device Name: STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 22435806
• Report Number: 1316463-2025-00068
• Device Sequence Number: 3152536
• Product Code: HMF
• UDI-Device Identifier: 00732094136722
• UDI-Public: 732094136722
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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
• Device Model Number: 77754
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown