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

Model Number C0600

Device Problems Air Leak (1008); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident device is anticipated to return.A follow-up report will be provided 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

Laparoscopic procedure - "seal is leaking: air comes out of the seal.And the lap.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 use of heatet instruments and they as well did not insert or remove gauze." patient status "ok.".

Manufacturer Narrative

Additional information was requested and provided.This report is related to mdr report # 202711-2015-00921, cer # (b)(4).Investigation summary: two (2) 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 and shield to be torn.Drag force testing was conducted on both 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 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 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 (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5325112
• MDR Text Key: 34925949
• Report Number: 2027111-2015-00922
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K943489
• 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: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• 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?: No
• 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