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

Model Number	A3203
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has 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 - the doctor mentioned to the instrument specialist that when the insert is attached to the jaw it is difficult for the clamp to maintain clapped in the locked position.The doctor used the a0c02 inserts.Applied medical received additional information on march 14,2017 from the customer via phone: the customer has confirmed that when the jaw is clamped closed it would easily unclasp.If the handle were to be tapped the clamp would release.Prevac steam was used to sterilization.(b)(4).Type of intervention: unk.Patient status: the caller was not informed of any patient injury.
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 and second ratchet positions were able to disengage with little force and the third ratchet was not able to engage.The ratchet teeth of the event unit had rounded edges and a polished surface, which indicated that the unit had experienced heavy use.It is likely that ratchet teeth were worn due to normal use over time, which would cause disengagement of the locking mechanism.Based on the rounded edges and polished surfaces of the ratchet teeth, 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: 6462411
• Report Number: 2027111-2017-01631
• Device Sequence Number: 10881596
• Product Code: DXC
• UDI-Device Identifier: 00607915112721
• UDI-Public: (01)00607915112721(11)140422(30)01(10)1221104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K950492
• 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): 05/11/2017

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: A3203
• Device Catalogue Number: 100497301
• Device Lot Number: 1221104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/11/2017
• Patient Sequence Number: 1