MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS22, 12X100 KII SLEEVE ADVFIX 12/BX; GCJ

Model Number	CFS22
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterile unit was returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
This cer is created for a sterile product returned from (b)(4) (reference mdr# 2027111-2017-01348).Incident description for (b)(4): nach dem cer teil 1 habe ich persönlich diese charge geprüft, und leider ist die trokarhülse bei leichtem druck zwischen daumen und zeigefinger am unteren ende unter dem ballon gebrochen.Der kunde möchte somit auch diese trokare zurück schicken und ersatz haben.Der kunde möchte den bericht direkt.Translion matthias hippler: after the first issue, dana tested a sterile product from the same lot no with the same result.With a soft pressure between thumb and index finger the distal part of cannula near the balloon was broken.The customer wants to swap out the complete stock of this lot no.The customer is asking for a direct full report.Patient status: na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation inside its sterile packaging.Upon visual inspection, engineering noticed a slight fracture at the cannula tip.The exact root cause of the cannula tip fracture could not be determined.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 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: CFS22, 12X100 KII SLEEVE ADVFIX 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6540298
• Report Number: 2027111-2017-01744
• Device Sequence Number: 13736747
• Product Code: GCJ
• UDI-Device Identifier: 00607915117740
• UDI-Public: (01)00607915117740(17)190512(30)01(10)1270769
• Combination Product (Y/N): N
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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: 05/12/2019
• Device Model Number: CFS22
• Device Catalogue Number: 101245301
• Device Lot Number: 1270769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1