MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB73, 12X100 KII SH BLD ZTHR 6/BX; GCJ

Model Number	CTB73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
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
Procedure performed: "ovarian cyst." event description: "a distal end(tip) of the trocar has been broken in the patient body.The patient was transferred to bigger hospital to have another treatment to get rid of the residue of trocar.Expension of hospitalization is necessary for this additional treatment." additional information received via email on 30may2018 from applied medical team member: "it was a ovarian case in [hospital name] hospital for women at (b)(6) 2018.Dr.[doctor's name] found the broken part of the cannula tip in all steps of surgery, but, he couldn't find where the remain part was.So, the patient was transferred to a general hospital to find the tip.Finally, the broken tip was seen in the patient's abdomen throughout reviewing the video record of surgery.The part was successfully removed from the patient's body.It is reported that there has not been harm and problem happened in the patient side with this so far." patient status: "it is reported that there has not been harm and problem happened in the patient side with this so far." "safe".
Additional Manufacturer Narrative
Correction: "foreign" was added as a report source.The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a fractured cannula tip.Based on the condition of the returned unit and the description of the event, it is likely that the tip fracture was caused by a combination of the following: an instrument that was not fully closed before it was removed from the trocar and a material abnormality, which could cause the cannula to be more susceptible to damage.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 has recently implemented process enhancements intended to further minimize the potential for this type of event to occur.The event unit was manufactured prior to the implementation of the process enhancements.

• Brand Name: CTB73, 12X100 KII SH BLD ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7555572
• Report Number: 2027111-2018-00192
• Device Sequence Number: 16459101
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727(17)181116(30)01(10)1259416
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K072674
• 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): 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/16/2018
• Device Model Number: CTB73
• Device Catalogue Number: 101219601
• Device Lot Number: 1259416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/16/2018
• 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: Hospitalization; Other