MAUDE Adverse Event Report: APPLIED MEDICAL C0600, UNIVERSAL SEAL, (PETALS) 20/BX; GCJ

Model Number C0600

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Event Description

Lap.(b)(6) - "air comes out of the seal and the instruments moving very bad through the seal.There is a strong resistance when pushing them forwards and backwards.Prof.(b)(6), chief urologist, told me, there was no heater instruments and they as well did not insert or remove gauze.".

Manufacturer Narrative

Additional information was requested and provided.This report is related to mdr report numbers 2027111-2015-00931, 2027111-2015-00932 ((b)(4)).Investigation summary: three (3) event units were returned for evaluation.Upon inspection of the first unit, engineering performed leak testing and found the unit functioned properly and met design specifications.Upon inspection of the second unit, engineering found the inner diameter of the septum was torn and the tips of the shield were damaged.Engineering also noted the petals of the duckbill were not fully closed.Upon inspection of the third unit, engineering noted no visible damage.Leak testing was performed on the third unit and the unit leaked with a test rod inserted.Drag force testing was conducted on all three units by inserting and removing a test rod multiple times and no excessive resistance was noted.All seals are thoroughly inspected and tested 100% for leakage during the manufacturing process.The damage to the septum and shield on the second unit was most likely caused by the repeated insertion or removal of the instruments used during the procedure and resulted in leakage from the seal.There is always a potential to tear or dislodge the internal seal components with multiple passes of instruments, especially with sharp or angular devices.The instructions for use (ifu) warns that extra care should be used when inserting angular and asymmetrical instruments.All instruments should be centered axially when inserted through the seal to prevent tearing.The exact root cause of the seal leakage in the third unit is unknown.However, the leakage may have been caused by an instrument remaining inserted in the trocar for a prolonged period of time.If the instrument remains inserted in the trocar for a prolonged period, it may prevent the seal from sealing properly.The root cause of the excessive resistance remains unknown as engineering was unable to replicate the incident.Although the root cause could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: C0600, UNIVERSAL SEAL, (PETALS) 20/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5338881
• MDR Text Key: 35257425
• Report Number: 2027111-2015-00930
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/21/2018
• Device Model Number: C0600
• Device Catalogue Number: 100817701
• Device Lot Number: 1245085
• Other Device ID Number: 00607915114831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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