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	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Facility; [user facility].Procedure performed: ni.Event description: client used this device for over three years.The bottle mouth has become irregularity.Customer understand that will reduce the bottle heat preservation function.But it was almost impossible that warmer bottle loses the function totally.The water in this bottle only keeps warm in a short time recently.Product is available for return.Additional information received on 25jul2022 via email from [name], [facility] purchasing representative.Image of bottle mouth attached.Patient status: before use - na.Type of intervention: ni.
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Facility; [user facility] procedure performed: ni.Event description: client used this device for over three years.The bottle mouth has become irregularity.Customer understand that will reduce the bottle heat preservation function.But it was almost impossible that warmer bottle loses the function totally.The water in this bottle only keeps warm in a short time recently.Product is available for return.Additional information received on 25jul2022 via email from [name], [facility] purchasing representative.Image of bottle mouth attached.Patient status: before use - na.Type of intervention: ni.
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 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.Based upon the initial description of the event, the event was not reportable as it is unlikely to cause or contribute to death or serious injury.However, based on the evaluation of the returned unit, applied medical determined that this event is reportable as a broken bottle weld is likely to cause or contribute to death or serious injury.

• 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: 15495002
• Report Number: 2027111-2022-00742
• Device Sequence Number: 14695435
• Product Code: GCJ
• UDI-Device Identifier: 00607915116798
• UDI-Public: (01)00607915116798(11)180316(30)01(10)1320566
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: 1320566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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