MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS22, 12X100 KII SLEEVE ZTHR 12/BX; GCJ

Model Number	CTS22
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Cer # 2018-100565 will address event device 1 of 2.Cer # 2018-100566 will address event device 2 of 2.Event description: the doctor reported two incidents of the sleeve tip bending.The doctor reported having trouble while trying to introduce the trocar.The tip of the sleeve bent.The doctor tried to repair the bend unsuccessfully.The sleeve was replaced and the same thing occurred.The doctor has used the devices before and was not new to the device.The rep was not present during the case.The obturator was inside while the doctor tried to introduce the trocar.No injury occurred.The patient is (b)(6).Both devices are available for return.Additional information was received via email on 21sep2018 from regulatory affairs.At the umbilicus port i tried to introduce the trocar more than once, when i noticed the tipo of the trocar was bend or irregular.I tried a second one and happened the same thing.I had to cut the aponeurosis with hasson technique.The surgeon did mentioned he tried to unbend the sleeve with tweezers (kelly or similar) in the or.Additional instruments used were laparoscopic instruments.Patient status: healthy.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy cer#: (b)(4) will address event device 1 of 2.Cer#:(b)(4) will address event device 2 of 2.Event description: the doctor reported two incidents of the sleeve tip bending.The doctor reported having trouble while trying to introduce the trocar.The tip of the sleeve bent.The doctor tried to repair the bend unsuccessfully.The sleeve was replaced and the same thing occurred.The doctor has used the devices before and was not new to the device.The rep was not present during the case.The obturator was inside while the doctor tried to introduce the trocar.No injury occurred.The patient is 36 years old.Both devices are available for return.Additional information was received via email on 21sep2018 from regulatory affairs: at the umbilicus port i tried to introduce the trocar more than once, when i noticed the tip of the trocar was bend or irregular.I tried a second one and happened the same thing.I had to cut the aponeurosis with hasson technique.The surgeon did mentioned he tried to unbend the sleeve with tweezers (kelly or similar) in the or.Additional instruments used were laparoscopic instruments.Patient status: healthy.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a damaged cannula tip.At this time, applied medical is unable to determine the root cause of the damaged cannula tip.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: CTS22, 12X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empressa; rancho santa margarita CA 92688
• MDR Report Key: 8117446
• Report Number: 2027111-2018-00448
• Device Sequence Number: 252204
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734(17)210529(30)01(10)1327156
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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: Health Professional
• Device Expiration Date: 05/29/2021
• Device Model Number: CTS22
• Device Catalogue Number: 101244801
• Device Lot Number: 1327156
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAPAROSCOPIC INSTRUMENTS
• Patient Age: 36 YR