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

Model Number	CFS22
Medical Device Problem Code	Break (1069)
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 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.
Event or Problem Description
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 - unknown.
Additional Manufacturer Narrative
Correction: the incident date was (b)(6) 2017.The event unit was returned to applied medical for evaluation along nine sterile units.Upon inspection of the event unit, engineering was able to confirm the complainant's experience of cannula tip fracture.The event unit did not appear to have been used on a patient.No damage was observed on the sterile units and all units met current specifications.Additional information was requested from the complainant inquiring whether the event unit was broken by the complainant, but no response was received.The likely root cause of the cannula tip fracture is intentional force applied to the units by the complainant.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.
Event or Problem Description
Additional information received via email at 12:49 am on may 09, 2017 from team member: she doesn't remember how many trocars were broken between her fingers.

• 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: 6365133
• Report Number: 2027111-2017-01348
• Device Sequence Number: 13462025
• 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: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• 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