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

Model Number A3213

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2017

Event Type  malfunction  

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 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.

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)
• Type of Device: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: jennifer scoullar ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497133904
• MDR Report Key: 6380723
• MDR Text Key: 69167869
• Report Number: 2027111-2017-01463
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607915112691
• UDI-Public: (01)00607915112691(11)310623(30)01(10)1271741
• Combination Product (y/n): N
• PMA/PMN Number: K962668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1