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

Model Number	C3001
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.After trying to sterilize the scope warmer, some liquid got stucked inside.The hospital doesn't think this is the right performance of the product.They bought another one and they haven't had any problem with it.Intervention: they bought another one and they haven't had any problem with it.Patient status: no clinical consequences have been reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the presence of water between the walls of the scope warmer bottle.Based on the condition of the returned unit, it is likely that there was a pin hole located on the interior walls of the scope warmer bottle, which expanded during the sterilization process and allowed water to enter the area in between the walls of the scope warmer bottle.However, the exact root cause of the pinhole could not be determined based on the evaluation of the returned unit.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.After trying to sterilize the scope warmer, some liquid got stucked inside.The hospital doesn't think this is the right performance of the product.They bought another one and they haven't had any problem with it.Intervention: they bought another one and they haven't had any problem with it.Patient status:no clinical consequences have been reported.

• 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
• MDR Report Key: 11673494
• Report Number: 2027111-2021-00453
• Device Sequence Number: 2998979
• Product Code: GCJ
• UDI-Device Identifier: 00607915116798
• UDI-Public: (01)00607915116798(11)191216(30)01(10)1377153
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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: 1377153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1