MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF75, 12X100 KII FIOS Z-THREAD DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF75
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
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 investigation.
Event or Problem Description
Procedure performed: unknown.Event description translation ame: during the operation, the trocar broke in two.Part of it remained in the patient, and was very difficult to recover.Information from the cro: "placement of two 10mm trocars in right hypochondrium and in the umbilicus.Placement of a 5mm trocar in the right subcostal area.Placement of a [brand name] retractor.The left pedicle is initially freed.Gastrolysis is performed with the help of the ultracision.The umbilical trocar fragments into 2 pieces.These are removed via the left hypochondrium trocar." additional information received from the customer via email on 18feb2020: there were more than three trocars, five in all i'd say.So there was one in the left hypochondrium.I don't remember exactly which dm was in place in the trocar that broke, but it was either the ultracutter or a laparoscopic grasping forceps as it was before the stapling.Intervention: removal of separated piece.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula.The wall thickness of the cannula was measured and found to be uneven.Based on the condition of the returned unit, it is likely that the cannula fracture was caused by the uneven cannula wall thickness, which occurred during the injection molding process of the cannula.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: unknown.Event description: translation ame: during the operation, the trocar broke in two.Part of it remained in the patient, and was very difficult to recover.Information from the cro: "placement of two 10mm trocars in right hypochondrium and in the umbilicus.Placement of a 5mm trocar in the right subcostal area.Placement of a [brand name] retractor.The left pedicle is initially freed.Gastrolysis is performed with the help of the ultracision.The umbilical trocar fragments into 2 pieces.These are removed via the left hypochondrium trocar." additional information received from the customer via email on 18feb2020: there were more than three trocars, five in all i'd say.So there was one in the left hypochondrium.I don't remember exactly which dm was in place in the trocar that broke, but it was either the ultracutter or a laparoscopic grasping forceps as it was before the stapling.Intervention: removal of separated piece.Patient status: no patient injury.

• Brand Name: CTF75, 12X100 KII FIOS Z-THREAD DP 10/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: 9771228
• Report Number: 2027111-2020-00393
• Device Sequence Number: 10909286
• Product Code: GCJ
• UDI-Device Identifier: 00607915129903
• UDI-Public: (01)00607915129903(17)220610(30)01(10)1360617
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 06/10/2022
• Device Model Number: CTF75
• Device Catalogue Number: 101473279
• Device Lot Number: 1360617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/09/2020
• 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: GENZYME RETRACTOR, ULTRASONIC DEVICE