MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G-8655, 86MM INSERT F/F 15/BX; DXC

Model Number	G-8655
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
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.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Procedure unknown: the inserts seemed to approximate tightly at the proximal end of the clamp jaws but the distal end was slightly gapped.We have ordered 2 new v.Mueller clamps and one seems to work with the inserts and one doesn't.These inserts were used in a procedure but i'm not sure if they were from the same lot or not.Patient status - no patient injury.
Additional Manufacturer Narrative
Investigation summary: the event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.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: G-8655, 86MM INSERT F/F 15/BX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6312195
• Report Number: 2027111-2017-01281
• Device Sequence Number: 36469
• Product Code: DXC
• UDI-Device Identifier: 00607915111298
• UDI-Public: (01)00607915111298(17)210828(30)01(10)1277979
• 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): 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 Expiration Date: 08/28/2021
• Device Model Number: G-8655
• Device Catalogue Number: 101369701
• Device Lot Number: 1277979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 05/11/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: V. MUELLER CLAMP