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

Model Number	C3001
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has returned for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown.Event description: [hospital].This is a complaint from the market.Report from the sales rep via email; despite the bottle being empty, it sounded like it was filled with water.This unit will be returned.Type of intervention: unknown.Patient status: na (before use).
Event or Problem Description
Procedure performed: unknown.Event description: [hospital].This is a complaint from the market.Report from the sales rep via email; despite the bottle being empty, it sounded like it was filled with water.This unit will be returned.Type of intervention: unknown.Patient status: na (before use).
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of water inside the walls of the bottle.The weld at the top lip of the bottle was broken.Dents were also observed on the top lip of the bottle.Based on the condition of the returned unit, it is likely that reported event was caused by improper care during handling of the unit.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

• Brand Name: 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19590353
• Report Number: 2027111-2024-00709
• Device Sequence Number: 16982712
• Product Code: GCJ
• UDI-Device Identifier: 00607915116798
• UDI-Public: (01)00607915116798(11)221010(30)01(10)1467325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 1467325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2024
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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