MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0E06, CANNULA 12MM SS REUS; GCJ

Model Number C0E06

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

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: unk.Event description: in an evaluation, a surgeon experienced that the 12mm port scraped the plastic coating off two of the instruments, leaving debris inside the patient.The surgeon was able to remove the debris.This is a first-time issue for this customer.The surgeon had not ever used the metal cannulas/trocars with disposable caps before.The customer has reported that the cannulas do seem sharp at the end.The sales rep collected the event sample and confirmed that it is sharp, but not much more sharp than the ones in her demo stock and another the customer had in stock. the event sample and one of the other ones the customer had in stock, along with two obturators (one sharp and one blunt), are available for return.Additional information received via email from regulatory specialist on wednesday, 16jan2019: reusable lap instruments were placed down through the 12mm port applied medical devices.Unsure if both units that are returning were used in the procedure.They only have four lap chole sets all together.It is likely both are used in the procedure.He was able to finish up laparoscopically but he had to fish out pieces of insulation from inside the patient.Type of intervention: the surgeon was able to remove the debris.Patient status: no adverse outcomes reported.

Event Description

Procedure performed: unknown.Event description: in an evaluation, a surgeon experienced that the 12mm port scraped the plastic coating off two of the instruments, leaving debris inside the patient.The surgeon was able to remove the debris.This is a first-time issue for this customer.The surgeon had not ever used the metal cannulas/trocars with disposable caps before.The customer has reported that the cannulas do seem sharp at the end.The sales rep collected the event sample and confirmed that it is sharp, but not much more sharp than the ones in her demo stock and another the customer had in stock.The event sample and one of the other ones the customer had in stock, along with two obturators (one sharp and one blunt), are available for return.Additional information received via email from regulatory specialist on wednesday, 16jan2019: reusable lap instruments were placed down through the 12mm port applied medical devices.Unsure if both units that are returning were used in the procedure.They only have four lap chole sets all together.It is likely both are used in the procedure.He was able to finish up laparoscopically but he had to fish out pieces of insulation from inside the patient.Type of intervention: the surgeon was able to remove the debris.Patient status: no adverse outcomes reported.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation along with an additional reusable cannula and two reusable obturators.Visual inspection of the event unit noted multiple dents and chips at the cannula tip.Testing was performed on the event unit, which confirmed the reported event.No damages were observed on the additional cannula and obturators.Based on the condition of the event unit, it is likely that the damage to the insulation of other instruments was caused by the dents and chips at the cannula tip, which resulted from the way in which the unit was handled.The instructions for use (ifu) states, "prior to use, inspect the distal tip of the cannula for any dents or tip damage that may have occurred during handling and cleaning.Dents, nicks, or cracks in the distal tip of the cannula may prevent proper shield deployment, increase the potential for cannula fracture, and may render the cannula incompatible with certain instruments.Cannula with damaged tips should not be used." 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: C0E06, CANNULA 12MM SS REUS
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8316607
• MDR Text Key: 138123628
• Report Number: 2027111-2019-00339
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 03/25/2019

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: C0E06
• Device Catalogue Number: 101079701
• Device Lot Number: 1279974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1