MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number C0R47

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed that a piece of the septum, an internal rubber component of the seal, had separated from the seal.Engineering also observed that the shield, an internal plastic component of the seal, was dislodged within the seal.Applied medical has reviewed the details surrounding the event and related product.At this time, applied medical is unable to determine the root cause of the customer¿s experience.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Septum fragmentation is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury.However, the event is reportable due to the dislodged shield that was observed during the evaluation of the returned unit.

Event Description

Procedure performed: unknown.Event description: this is a complaint from the market.Please refer to the complaint sheet for investigation.Large resistance of the insertion , and detachment of the septum.Report from the sales rep: after four hours, the resistance of insertion the scope had increased and the septum was popped out when removed from seal component.Initial investigation report: the event unit was returned to us and visually inspected.The septum was detached from the seal component.No visual damage was found in the ddb and shield.The unit will be returned to amr for further evaluation.Patient status: no patient injury.

• Brand Name: C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 10005738
• MDR Text Key: 189476442
• Report Number: 2027111-2020-00457
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0R47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1