MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A0801, 33MM INSERT S/T 10/BX; DXC

Model Number	A0801
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2017
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 the investigation.
Event or Problem Description
Procedure performed: unknown.Incident description: "the tech placed the inserts into the clamp.She handed the clamp directly to the surgeon and when he opened the clamp the inserts fell out.The tech then placed another set of inserts (from the same lot number) into the clamp.They stay in the clamp securely." type of intervention: "the tech then placed another set of inserts (from the same lot number) into the clamp.They stay in the clamp securely." patient status: "patient was not harmed".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a detached insert.Based on the condition of the returned unit, it is likely that the reported event was caused by the attachment buttons of insert that were not fully formed during the injection molding process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function, and ease of use of its products.As part of this process, applied medical has recently implemented process enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: A0801, 33MM INSERT S/T 10/BX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7068004
• Report Number: 2027111-2017-02129
• Device Sequence Number: 127058
• Product Code: DXC
• UDI-Device Identifier: 00607915113360
• UDI-Public: (01)00607915113360(17)220206(30)01(10)1289547
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K883790
• 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): 01/10/2018

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 Expiration Date: 02/06/2022
• Device Model Number: A0801
• Device Catalogue Number: 101372301
• Device Lot Number: 1289547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/10/2018
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1