MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR01, 5X150 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: hysteroscopy d&c & endometrial ablation [] & pap smear, laparoscopy left oophorectomy.Event description: "snapped during entry, with minimal force (per surgeon).Broken segment became lodged inside patient.Trocar remained in tact." additional information received from user facility via email on 7 august 2019: dr.[name] continued to look for the segment laparoscopically until it was found and removed.The patient's current status is stable, discharged.The lot number of the product is 1317273.The name of the procedure is hysteroscopy d&c & endometrial ablation [] + pap smear, laparoscopy left oophorectomy.Type of intervention: segment was found and removed.Patient status: stable, discharged.
Event or Problem Description
Procedure performed: hysteroscopy d&c & endometrial ablation & pap smear, laparoscopy left oophorectomy.Event description: "snapped during entry, with minimal force (per surgeon).Broken segment became lodged inside patient.Trocar remained intact".Additional information received from user facility via email on 7 august 2019: dr.[name] continued to look for the segment laparoscopically until it was found and removed.The patient's current status is stable, discharged.The lot number of the product is 1317273.The name of the procedure is hysteroscopy d&c & endometrial ablation + pap smear, laparoscopy left oophorectomy.Type of intervention: segment was found and removed.Patient status: stable, discharged.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by uneven 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.

• Brand Name: CTR01, 5X150 KII OPT ZTHR 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: 8916042
• Report Number: 2027111-2019-00566
• Device Sequence Number: 503075
• Product Code: GCJ
• UDI-Device Identifier: 00607915124045
• UDI-Public: (01)00607915124045(17)210208(30)01(10)1317273
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 02/08/2021
• Device Model Number: CTR01
• Device Catalogue Number: 101412801
• Device Lot Number: 1317273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1