MAUDE Adverse Event Report: WELCH ALLYN INC. GS 777 WALL TRANSFORMER W/OPHTH & OTO UK; TRANSFORMER, ENDOSCOPE

Model Number	77754
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded by the customer so inspection could not be performed to determine a root cause of the reported event.Per the technician, there was no evidence to show what caused the sparking.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 ac plug were to spark 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 has evidence of sparking.Black soot all throughout the connector between the plug body and the inbuilt uk plug socket adapter.There was no adverse event reported.

• Brand Name: GS 777 WALL TRANSFORMER W/OPHTH & OTO UK
• Common Device Name: TRANSFORMER, ENDOSCOPE
• 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: 22931740
• Report Number: 1316463-2025-00076
• Device Sequence Number: 10294569
• Product Code: GCW
• 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
• Report Date (Section B): 09/01/2025

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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