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

Model Number	C3001
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure: prostatectomy with robot assistance.The responsible nurse ((b)(6)), mr.[name], tells me that the product makes a liquid noise when handled.This noise has always been present (it would have been bought in early 2020).The product has already been used on the block.Currently, surgeons no longer wish to use it as long as this noise is present.No liquid leaks directly visible.No impact on a patient.Additional information received by email from applied medical representative on 24june2020: name of procedure being performed: for 95% for surgical procedures: prostatectomy with robot assistance.The canister is rusting or corroding.The base did not break.The canister is dented.There is a presence of water between the canister walls.The customer specifies however that the noise of water inside the device was already present during its delivery.Patient status: no patient injury or illness occurred associated with the complaint event.Type of intervention: ni.
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.Engineering observed that the scope warmer bottle had rust, corrosion, and was dented.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.Due to the manufacturing date of the returned unit, it is possible that the pin hole was caused by regular usage of the device.The probability and criticality of harm resulting from this failure have been evaluated and were found to be an acceptable level.
Event or Problem Description
Name of procedure: prostatectomy with robot assistance.The responsible nurse (cadre de bloc), mr.[name], tells me that the product makes a liquid noise when handled.This noise has always been present (it would have been bought in early 2020).The product has already been used on the block.Currently, surgeons no longer wish to use it as long as this noise is present.No liquid leaks directly visible.No impact on a patient.Additional information received by email from applied medical representative on 24june20: name of procedure being performed: for 95% for surgical procedures: prostatectomy with robot assistance.The canister is rusting or corroding.The base did not break.The canister is dented.There is a presence of water between the canister walls.The customer specifies however that the noise of water inside the device was already present during its delivery.Patient status: no patient injury or illness occurred associated with the complaint event.Type of intervention: ni.

• 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: 10260957
• Report Number: 2027111-2020-00500
• Device Sequence Number: 19483713
• Product Code: GCJ
• UDI-Device Identifier: 00607915116798
• UDI-Public: (01)00607915116798(11)180507(30)01(10)1324361
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 08/31/2020

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: 1324361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1