MAUDE Adverse Event Report: WELCH ALLYN 3 .5V RCHG HANDLE F/DESK CHGR; EXOPHTHALMOMETER

Model Number	71670
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the ophthalmoscope handle shorted out dr had the handle in their lab coat and it burnt a whole in their pants but did not burn the skin.The doctor stated that the handle became very hot and smoked and they could smell something burning.There was no adverse event reported.
Additional Manufacturer Narrative
The device has been requested to be returned for inspection.A final report will be submitted upon completion of the investigation.
Event or Problem Description
Customer reported the ophthalmoscope handle shorted out dr had the handle in their lab coat and it burnt a whole in their pants but did not burn the skin.The doctor stated that the handle became very hot and smoked and they could smell something burning.There was no adverse event reported.
Additional Manufacturer Narrative
The device was returned for inspection where it was determined that the battery assembly had split and looked like it had melted.Diagnostic sets are among the most critical toolsets in a clinician's repertoire to perform a comprehensive physical exam.Welch allyn diagnostic sets help physicians perform fast exams and accurately diagnose a range of patient conditions thanks to innovative optical technologies that help clinicians get wider views of the optic disc.In addition to examination of the fundus, the ophthalmoscope is a useful diagnostic aid in studying other ocular structures.The light beam can be used to illuminate the cornea and the iris for detecting foreign bodies in the cornea and irregularities of the pupil.The handles are intended to power various accessory heads including otoscopes, ophthalmoscopes, retinoscopes, strabismoscopes, episcopes, illuminators, and transilluminators.The battery and handle were replaced for the customer.Based on this information, no further actions are required at this time.Reports of thermal/electrical damage to an internal component do not represent a hazardous situation to the end user as the device is not intended to be held by the end user and therefore decreases the likelihood of severe injury or death to negligible.

• Brand Name: 3 .5V RCHG HANDLE F/DESK CHGR
• Common Device Name: EXOPHTHALMOMETER
• Manufacturer (Section D): WELCH ALLYN; 4341 state street; skaneateles NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 23477409
• Report Number: 1316463-2025-00090
• Device Sequence Number: 10237529
• Product Code: HLS
• UDI-Device Identifier: 00732094140293
• UDI-Public: 732094140293
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 01/02/2026

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: 71670
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/02/2026
• 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