MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR33, 11X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	5
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Thoracoscopy - "sleeve from cfr33 got pressed against ribs of patient and pieces got into the cavity." additional information received from sales rep on 24 march 2017: the model of the product is cfr33 with lot # 1282053.The procedure was thoracoscopy using 1 trocar and only the sleeve.Sleeve had (cracked) broken but no pieces ended up in patient.Patient is ok.Patient status: "ok.".
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a representative sterile unit from the same lot was returned.Upon visual inspection, there were no signs of damage on the unit.In the absence of the subject device, it is difficult to determine the root cause of the event.Although the event unit was not returned and the complainant's experience could not be confirmed, the likely root cause of the cannula tip fracture is due to force applied on the trocar in combination with lipid exposure.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: CFR33, 11X100 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6474306
• Report Number: 2027111-2017-01689
• Device Sequence Number: 605980
• Product Code: GCJ
• UDI-Device Identifier: 00607915123222
• UDI-Public: (01)00607915123222(17)191021(30)01(10)1282053
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: 5
• 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): 05/31/2017

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: 10/21/2019
• Device Model Number: 5
• Device Catalogue Number: 5
• Device Lot Number: 1282053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1