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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: na (before use).[facility].This is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation.Report from the sales rep: when pouring hot water into c3001 and holding the canister in preparation for the procedure, the outer surface became too hot to hold.The case was completed with the same one.This was the first time they had used it.We tried to check what temperature hot water was put in, but did not get an answer due to the covid-19.Initial investigation report the event unit was returned to us and visually inspected.The inner surface of the bottle was seemed to be scratched (pic.1).The unit will be returned to amr for further evaluation.Admin# (b)(6).Products available for return: 1 bottle.Patient status: (before use).Type of intervention: (before use).
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience of heat transfer could not be replicated or confirmed.The event unit met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction - h5: labeled for single use was updated from yes to no.
Event or Problem Description
Procedure performed: na (before use).Event description: [facility] this is a complaint from the market.Administrative no.(b)(4).Report from the sales rep: when pouring hot water into c3001 and holding the canister in preparation for the procedure, the outer surface became too hot to hold.The case was completed with the same one.This was the first time they had used it.We tried to check what temperature hot water was put in, but did not get an answer due to the covid-19.Initial investigation report the event unit was returned to us and visually inspected.The inner surface of the bottle was seemed to be scratched (pic.1).The unit will be returned to amr for further evaluation.Admin# (b)(4).Products available for return: 1 bottle.Patient status: na (before use).Type of intervention: na (before use).

• 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: 15591514
• Report Number: 2027111-2022-00773
• Device Sequence Number: 2236568
• Product Code: GCJ
• UDI-Device Identifier: 00607915116798
• UDI-Public: (01)00607915116798(11)211209(30)01(10)1438209
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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: Other
• Device Model Number: C3001
• Device Catalogue Number: 100260501
• Device Lot Number: 1438209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown