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

Model Number	C3001
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.From cer form: i received an email from customer services advising the below, we were contacted on the 29th of january and were advised the incident happened "last week", so i am unsure of the actual event date."the have a scope warmer ct3001 lot 1320569.They have used it since purchase, but last week after it washed it has started to rattle.They think it might the insulation coming off but they are not sure.They want to know if it's under warranty." intervention: na.Patient status: na.
Event or Problem Description
Procedure performed: unknown.The have a scope warmer ct3001, lot 1320569.They have used it since purchase, but last week after it washed it has started to rattle.They think it might the insulation coming off but they are not sure.They want to know if it¿s under warranty.From cer form: i received an email from customer services advising the below, we were contacted on the 29th of january and were advised the incident happened "last week", so i am unsure of the actual event date.Intervention: na.Patient status na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed that the scope warmer bottle rattled when it was shaken.Engineering observed that there was an incomplete weld at the top of bottle.Based on the condition of the returned unit, the reported event occurred during the manufacturing process at the 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 inspection enhancements intended to further minimize the potential for this type of event to occur.

• 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: 9803070
• Report Number: 2027111-2020-00408
• Device Sequence Number: 11513895
• Product Code: GCJ
• UDI-Device Identifier: 00607915116798
• UDI-Public: (01)00607915116798(11)180420(30)01(10)1320569
• 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,Followup
• Report Date (Section B): 03/24/2020

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: 1320569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1