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

Model Number C3001

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

Procedure performed: ni.Event description: "i share with you that we received a complaint from the customer regarding the thermos and base purchased in [invoice].The client indicates that at the time of washing the base came off.C3001 lot 1457755, c3002 lot 1456567" additional information was received on 10-oct-23 by email from [customer] "the incident occurred las (b)(6) 2023 , the hospitial still no confirm if the model c3002 also is involved in the complaint, the scope warmer was already used, the incident was after the procedure while the technician was cleaning the product.The product will be returned." type of intervention: ni.Patient status: good.

Manufacturer Narrative

The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: ni.Event description: "i share with you that we received a complaint from the customer regarding the thermos and base purchased in [invoice].The client indicates that at the time of washing the base came off.C3001 lot 1457755.C3002 lot 1456567".Additional information was received on (b)(6) 2023 by email from [customer] "the incident occurred las (b)(6) 2023 , the hospitial still no confirm if the model c3002 also is involved in the complaint, the scope warmer was already used, the incident was after the procedure while the technician was cleaning the product.The product will be returned.".Additional information was received on tuesday (b)(6) 2023 by e-mail from [customer] / tittle unk) "the client confirmed that item c3002 was not involved, and the event took place at [facility], confirmation if the scope warmer seal (c3101) was used with the scope warmer bottle or not is still pending.".Type of intervention: ni.Patient status: good.

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 and outer canisters were completely separated.The weld connecting both walls was incomplete and part of the weld was broken.Based on the condition of the returned unit, the reported event occurred during the manufacturing process at the original bottle vendor¿s facility.Applied medical continuously seeks to improve the form, function, and ease of use of its products.As part of this process, applied medical is currently researching possible process and inspection enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: C3001, SCOPE WARMER BOTTLE
• Type of Device: 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: 17992143
• MDR Text Key: 326391406
• Report Number: 2027111-2023-00652
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915116798
• UDI-Public: (01)00607915116798(11)220622(30)01(10)1457755
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K931895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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
• Device Operator: Health Professional
• Device Model Number: C3001
• Device Catalogue Number: 100260501
• Device Lot Number: 1457755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1