MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUN MED; GREENLINE C/P LARGE HANDLE D

Model Number	5-0236-15
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: (appropriate term/code not available) g: device handle.The product involved in the report has not been returned for evaluation.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 16 may 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, the customer put the blade in it and the product [became] so hot they could not hold onto it anymore.There was no report of medical intervention.
Event or Problem Description
It was reported, the customer put the blade in it and the product [became] so hot they could not hold onto it anymore.There was no report of medical intervention.
Additional Manufacturer Narrative
H6: (appropriate term/code not available) g: device handle.H6: (appropriate term/code not available) d: internal short.Correction: d9.Additional information-investigation conclusion: h6.The product involved in the report was returned for evaluation.Functional testing, performed by the supplier revealed: the bulb turned on briefly and immediately became hot, an indication of a potential internal short circuit.The reported issue was confirmed.To validate the assumption, bulb was replaced and the blade on the handle was engaged and kept it on for 15 minutes; during this period, the handle remained fully functional with no signs of overheating.The root cause was determined to be an internal short circuit in the bulb, which resulted in abnormal heating and failure to illuminate; replacing the bulb resolved the issue completely.The device history record (dhr) review found no abnormal processing issues; all products/packaging were produced per the approved manufacturing procedures, specifications, and inspections.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 21 aug 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.

• Brand Name: SUN MED
• Common Device Name: GREENLINE C/P LARGE HANDLE D
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, ch 51917 0; CH 519170
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22038624
• Report Number: 1314417-2025-00027
• Device Sequence Number: 20863915
• Product Code: CCW
• UDI-Device Identifier: 10889483003060
• UDI-Public: (01)10889483003060
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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
• Operator of Device: Health Professional
• Device Model Number: 5-0236-15
• Device Catalogue Number: 792-5-0236-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/21/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown