MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A3213, CLAMP (SIZE 5-60); DXC

Model Number	A3213
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2017
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 - "(on (b)(6) 2017: during procedure) ratchets of the clamp a3213 were disengaged during a procedure.The ratchets pawls didn't engage to the other side properly.Medical staff confirmed that the ratchet pawls didn't match each other properly while preparing the procedure.This didn't affect the patient." type of intervention: unk.Patient status: no health damage was reported for the patient.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Testing confirmed the locking mechanism was functional.Upon further investigation, it was observed that the first four ratchets of the event unit were loose and were able to separate with minimal force.It is likely that ratchet teeth were worn due to normal use over time, which would cause reduced engagement of the locking mechanism.It is likely 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: A3213, CLAMP (SIZE 5-60)
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6380723
• Report Number: 2027111-2017-01463
• Device Sequence Number: 675971
• Product Code: DXC
• UDI-Device Identifier: 00607915112691
• UDI-Public: (01)00607915112691(11)310623(30)01(10)1271741
• Combination Product (Y/N): N
• PMA/510(K) Number: K962668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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: A3213
• Device Catalogue Number: 100792801
• Device Lot Number: 1271741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1