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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon inspection, engineering confirmed that the lip of the bottle was damaged and the outer walls of the scope warmer bottle had collapsed.Based on the condition of the returned unit, it is likely that the outer walls of the scope warmer bottle had collapsed during the sterilization process due to pinholes in the scope warmer bottle.The pinholes were likely caused by repeated usage of the scope warmer bottle over time.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: lap chole.At beginning of case, scope seal would not mount onto canister.Nurse said it was lip of canister was deformed and had been problematic for some time.As a result, during the case, the water became cold therefore device to serve purpose.Additional information received by email from applied medical representative on 25sep19: i am at the hospital now and have just spoken to [deputy theatre manager].She unfortunately cannot provide further information and the two theatre staff who were working that day are not here.Additional information received by phone from applied medical representative on 27sep19: you confirmed by phone that when you visited the hospital, they looked at the event record and did not find any information related to the patient status following the incident.In case there would have been any consequence on the patient, this would have been indicated in the hospital event record and communicated to you.Additional information received by email from applied medical representative on 17oct19: i have spoken to the staff member concerned, who confirms that the flask lip was damaged/bent before the procedure.This is at the beginning/setting up for the procedure as [company representative] has documented.Patient status: no indication of consequence on the patient.

• 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: 9453668
• Report Number: 2027111-2019-00658
• Device Sequence Number: 3039843
• Product Code: GCJ
• UDI-Device Identifier: 00607915116798
• UDI-Public: (01)00607915116798(11)121109(30)01(10)1182364
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K931895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C3001
• Device Catalogue Number: 100260501
• Device Lot Number: 1169138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1