MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR73, 12X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTR73

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

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 Description

Procedure performed: unknown.Event description: this is a complaint from the market.Administrative no.(b)(4).Report from the sales rep: the cannula was broken during the procedure.The case was completed with the new one.The customer said that the patient was in the lateral position and the patient's fixation was loosened and the patient moved.Therefore, the fixing was redone several times, and at that time the 3d retractor entered into the trocar, and that fixing was redone with the retractor in place, or the patient moved strangely.The customer guessed that the retractor was using at a considerable angle and the cannula was broken due to excessive force.Initial investigation report: the event unit was returned to us and visually inspected.The cannula was found to be bent and fractured.The unit will be returned to amr for further evaluation.Admin# (b)(4).Intervention: the case was completed with the new one.Patient status: no patient injury.

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 shaft and tip were measured.The wall thickness of the cannula shaft was uneven and did not meet specifications.Based on the condition of the returned unit and the description of the event, it is likely that the cannula fracture was caused by the uneven cannula shaft wall thickness, excessive forces applied to the cannula during the procedure, or a combination of both.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: unknown.Event description: this is a complaint from the market.Administrative no.(b)(4).Report from the sales rep the cannula was broken during the procedure.The case was completed with the new one.The customer said that the patient was in the lateral position and the patient's fixation was loosened and the patient moved.Therefore, the fixing was redone several times, and at that time the 3d retractor entered into the trocar, and that fixing was redone with the retractor in place, or the patient moved strangely.The customer guessed that the retractor was using at a considerable angle and the cannula was broken due to excessive force.Initial investigation report the event unit was returned to us and visually inspected.The cannula was found to be bent and fractured(pic.1).The unit will be returned to amr for further evaluation.Admin# c20515045.Additional information received via email on 24sep2020 from distributor: "no, it was not caused particlation." intervention: the case was completed with the new one patient status: no patient injury.

• Brand Name: CTR73, 12X100 KII OPT ZTHR 6/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10495167
• MDR Text Key: 206164513
• Report Number: 2027111-2020-00550
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680(17)230128(30)01(10)1379889
• Combination Product (y/n): N
• PMA/PMN Number: K060096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: CTR73
• Device Catalogue Number: 101219401
• Device Lot Number: 1379889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3D RETRACTOR