MAUDE Adverse Event Report: WELCH ALLYN, INC. GS 777 WALL TRANSFORMER US; STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC

Model Number	77710
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gs 777 wall transformer is intended to provide power to welch allyn 3.5v instruments.The device powers two instrument handles, onto which welch allyn 3.5v diagnostic instrument heads can be attached.These diagnostic instrument heads include the welch allyn otoscope, opthalmoscope and episcope.The wall transformer can be used alone, or as part of the gs 777 integrated wall system (iws), which incorporates other welch allyn devices, such as the suretemp thermometer, spot vital signs monitor and the probp 3400 and the aneroid blood pressure gauge.Although the reported event did not result in a serious injury, the report of frayed power cord could contribute to a serious injury or death, if the malfunction were to recur.Therefore, baxter considers this complaint a reportable malfunction.
Event or Problem Description
Customer reported frayed cord.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: GS 777 WALL TRANSFORMER US
• Common Device Name: STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 21419718
• Report Number: 1316463-2025-00020
• Device Sequence Number: 15351312
• Product Code: HMF
• UDI-Device Identifier: 00732094136906
• UDI-Public: 732094136906
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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: 77710
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/20/2025
• 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