MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A3220, SHORT HANDLE, SZ 5-40 DEG CLAMP; DXE

Model Number	A3220
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
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: aorta.Dr.Had to clamp the aorta but the cover of the clamp misaligned, preventing the use.This unit was shipped to them, new, last september so please check the original order because they do not have the details.Additional information received via email from applied medical rep 16nov2018: lot.Number confirmed to be 1309873.Patient status: no patient injury.Type of intervention: unknown.
Event or Problem Description
Procedure performed: aorta.[dr.] doveva camplare l'aorta, ma si è sovrapposto la copertura della clamp, impedendo l'utilizzo.Questo ferro è stato spedito loro nuovo a settembre, quindi rivedere l'ordine di allora perchè non hanno i dati translation into english: [ dr.] had to clamp the aorta but the cover of the clamp misaligned, preventing the use.This unit was shipped to them, new, last september so please check the original order because they do not have the details.Additional information received via email from applied medical rep 16nov2018: lot.Number confirmed to be 1309873.Patient status: no patient injury.Type of intervention: unknown.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the jaws of the clamp were misaligned.Engineering also observed rust and damage on the ratchet teeth and determined that the clamp was manufactured prior to 2002.Based on the condition of the returned unit, the reported event was caused by normal use over time.The wear observed on the event unit and the lot number of the device, suggest that the event unit had been used multiple times prior to the complainant¿s experience.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: A3220, SHORT HANDLE, SZ 5-40 DEG CLAMP
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8158304
• Report Number: 2027111-2018-00464
• Device Sequence Number: 2325119
• Product Code: DXE
• UDI-Device Identifier: 00607915114237
• UDI-Public: (01)00607915114237(11)171101(30(01(10)1309873
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K950492
• 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): 04/03/2019

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: A3220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 04/03/2019
• Patient Sequence Number: 1