MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A3203, SURGICAL CLAMP, SIZE 2, STRAIGHT; DXC

Model Number	2
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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: na.The customer was testing their clamps and identified that at when the jaw is clamped closed it would easily unlock.Type of intervention: na.Patient status: na.
Additional Manufacturer Narrative
Correction: as this is a reusable product, usage of product was updated to reflect "reuse." 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 clamp was able to disengage if sufficient force was applied to the handle.It is likely that ratchet teeth were worn due to normal use over time, which would cause reduced engagement of the locking mechanism.Based on the wear observed on the event unit, 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: A3203, SURGICAL CLAMP, SIZE 2, STRAIGHT
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6513663
• Report Number: 2027111-2017-01659
• Device Sequence Number: 749364
• Product Code: DXC
• UDI-Device Identifier: 00607915112721
• UDI-Public: (01)00607915112721(11)150428(30)01(10)1245476
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 2
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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: 2
• Device Catalogue Number: 2
• Device Lot Number: 1245476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2017
• Supplement Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1