MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R85, 12X100MM KII BLT TIP SYS 6/BX; GCJ

Model Number	C0R85
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2016
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.This report is to follow up to medwatch report # (b)(4).There is no report of serious injury or death associated with this event.
Event or Problem Description
Medwatch report."top piece fell off repeatedly.Would not stay clicked in.The procedure was completed with an identical item." what was the original intended procedure? not known.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working)" additional information received via e-mail from the customer on september 14, 2016: the staff did not indicate how the seal housing fell off or if it was easily removed.No indication was mentioned from the staff regarding whether or not the tabs were being pinched at the time of breakage.The device is available for return for evaluation and there was no injury to the patient.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Engineering was able to confirm the complainant's experience.The distance between the latch tabs was measured and was found to be out of specification.The root cause of the seal housing dislodgement is likely due to the distance between the two tabs not meeting specifications.The probability and criticality of harm resulting from this failure mode 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 is currently researching possible process enhancements intended to further minimize the potential for this type of incident to occur.The event is deemed as non-reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow up to medwatch report (b)(4).

• Brand Name: C0R85, 12X100MM KII BLT TIP SYS 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6024839
• Report Number: 2027111-2016-00683
• Device Sequence Number: 10988535
• Product Code: GCJ
• UDI-Device Identifier: 00607915118549
• UDI-Public: (01)00607915118549(17)171215(30)01(10)1259382
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• 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): 04/14/2017

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: 12/15/2017
• Device Model Number: C0R85
• Device Catalogue Number: 100964801
• Device Lot Number: 1259382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other