MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0E05, CANNULA 11MM SS REUS; GCJ

Model Number C0E05

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

Event Description

Procedure performed: unknown abdominal procedure.Event description: distal edge of product severely damaged laparoscopic insulation on 2 l-hooks.Insulation was stripped from instrument passing through cannula and fell into abdominal cavity.The outer distal opening edge appeared to be sharp causing the damage.Hospital will be reporting this to the health authority.Additional information received from distributor via email on 01nov2018: received clarification on product return status.It is not immediately available as it has been sent to their regional clinical engineers for investigation.Once their investigation is complete they will be sending the instrument back to the hospital.The hospital will then send it to [distributor ].We will then send it to applied.The hospital has confirmed that the patient did not receive any harm.Patient status: no adverse patient outcomes reported.The hospital has confirmed that the patient did not receive any harm.

Event Description

Procedure performed: unknown abdominal procedure.Event description: distal edge of product severely damaged laparoscopic insulation on 2 l-hooks.Insulation was stripped from instrument passing through cannula and fell into abdominal cavity.The outer distal opening edge appeared to be sharp causing the damage.Hospital will be reporting this to the health authority.Additional information received from distributor via email on 01nov2018: received clarification on product return status.It is not immediately available as it has been sent to their regional clinical engineers for investigation.Once their investigation is complete they will be sending the instrument back to the hospital.The hospital will then send it to [distributor ].We will then send it to applied.The hospital has confirmed that the patient did not receive any harm.Patient status: no adverse patient outcomes reported.The hospital has confirmed that the patient did not receive any harm.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.A visual inspection was performed on the event unit and multiple scratches were observed at the cannula tip.Testing was performed on the event unit, which confirmed the reported event.Based on the condition of the returned unit and the description of the event, the damage to the insulation of other instruments was caused by a sharp edge at the cannula tip, which was caused during manufacturing.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: C0E05, CANNULA 11MM SS REUS
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8102872
• MDR Text Key: 128428277
• Report Number: 2027111-2018-00439
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915115593
• UDI-Public: (01)00607915115593(11)330507(30)01(10)1324239
• Combination Product (y/n): N
• PMA/PMN Number: K932995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

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
• Device Operator: Health Professional
• Device Model Number: C0E05
• Device Catalogue Number: 100349701
• Device Lot Number: 1324239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 L-HOOKS