MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C3001, SCOPE WARMER BOTTLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C3001
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: na.Event description: translation: thermos bottle for use in laparoscopy.It is broken.Does not retain heat.From complaint form: according to the or nurses, the heated saline inside the scope warmer got cold to fast in the last times they used it.This scope warmer has, at least, 3+ years of daily use; according to hospital's information, it's broken and do not hold the heat and they sent us a repair order asking if we can correct the issue.They are aware that this product has a lot of use and is also subject to wear and tear.They understood that we do not repair this material.Intervention: change of device.Patient status: na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken scope warmer bottle.The inner wall of the bottle was detached from the outer wall of the bottle, and the weld line connecting both walls was broken.Multiple dents were observed on the top, bottom and outside of the bottle.Based on the condition of the returned unit, it is likely that reported event was caused by improper handling of the unit after it was shipped from applied medical.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C3001, SCOPE WARMER BOTTLE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13726193
• Report Number: 2027111-2022-00460
• Device Sequence Number: 6091040
• Product Code: GCJ
• UDI-Device Identifier: 00607915116798
• UDI-Public: (01)00607915116798(11)180420(30)01(10)1320569
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K931895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

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: C3001
• Device Catalogue Number: 100260501
• Device Lot Number: 1320569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2018
• 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