MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF71, KII FIOS 12X150MM Z-THREAD, 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic gastric sleeve.Event description: rep was not present for the case.Limited information is available at the time of report.When removing the trocar and obturator it was noticed that the tip of the obturator was broken.The surgeon was unable to locate the broken pieces of the obturator inside the patient.There is no patient injury to date, the procedure occurred "a few weeks ago." product available for return.Additional information was received via email on 16aug2021 from account manager i, applied medical: hospital risk management has not replied after multiple attempts and urging the or staff.The rep will continue to try to get additional information about the event.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the event.
Event or Problem Description
Procedure performed: laparoscopic gastric sleeve.Event description: rep was not present for the case.Limited information is available at the time of report.When removing the trocar and obturator it was noticed that the tip of the obturator was broken.The surgeon was unable to locate the broken pieces of the obturator inside the patient.There is no patient injury to date, the procedure occurred "a few weeks ago." product available for return.Additional information was received via email on (b)(6)2021 from account manager i, applied medical: hospital risk management has not replied after multiple attempts and urging the or staff.The rep will continue to try to get additional information about the event.Additional information was received via email on 20aug2021 from account manager i, applied medical: the rep had tried again and had gotten no further information past [their] last update.Patient status: no patient injury.

• Brand Name: CTF71, KII FIOS 12X150MM Z-THREAD, 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12337324
• Report Number: 2027111-2021-00606
• Device Sequence Number: 2806364
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)240407(30)01(10)1411607
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 04/07/2024
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1411607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 11/03/2021
• Patient Sequence Number: 1