MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH STABILITY SLEEVE FOR BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number CB5LT

Device Problem Air Leak (1008)

Patient Problems Surgery, prolonged (2177); Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 05/20/2015

Event Type  Injury  

Event Description

It was reported that during a total laparoscopic hysterectomy procedure, co2 air leak (causing abdomen deflated).Six types of suspected causes -- ports, vaginal cup, gas tubing, gas tubing adaptor, low level of gas tank, f) defect of karl storz's spies camera system (newly purchases by hospital), and didn't close harmonic jaw while removing it through working ports.Event chronology: air leaked only towards the end of surgery (during colpotomy).Didn't suspect leak from trocars initially.The doctor checked vaginal cup - problem persisted.Changed gas tubing.Problem persisted.Changed one of the three working ports (cb5lt).Didn't change main camera port (2b5lt).Noticed gas tank level was at low levels - changed to new gas tank.Air pressure still low and it fluctuated from 0-9.Changed adaptor tubing (a metal fastener that fastens the rubber gas tubing).Changed one more pc of cb5lt.Air leakage persisted - air pressure cannot be maintained and continue to fluctuate but a t low levels of 0-9.Changed to older version of karl storz's camera system set.Problem persisted.The doctor aborted surgery and proceeded to finish colpotomy trans-vaginally.Audible air hissing from ports were detected after a few minutes.Problem occurred laparoscopically.Delay of two hours.

Manufacturer Narrative

(b)(4).No device received for analysis at time of submission of 3500a when additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.The following information was requested, but unavailable: did they close the stopcock when the procedure was converted to vaginal? what model of the karl storz camera system was utilized? (what is the diameter?) was air hissing only noticed when a device was in the trocar or was it also noticed with no device was in the trocar? when did they notice air leaking; was it after noticing the insufflation levels were low?.

Manufacturer Narrative

(b)(4).Additional information: sleeve.The analysis results found that the cb5lt device was returned with the cap separated from the base.The plastic from the cap was noted to be brittle and the posts from the sleeve and the cap were observed to be broken.No functional testing could be performed to evaluate the reported insufflation issues due to the returned condition of the device.A potential cause of this condition is the repeated use of eto as a sterilization agent.Ees single-use trocars are not to be reused, reprocessed or re-sterilized.Our manufacturing batch history review identified that a leak issue was detected during the manufacturing of one of these lots.When this occurs, our quality system documents the necessary actions to ensure final product quality.The final quality release criteria was met before this batch was released for distribution.

• Brand Name: ENDOPATH STABILITY SLEEVE FOR BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 4844083
• MDR Text Key: 5871000
• Report Number: 3005075853-2015-03487
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2019
• Device Catalogue Number: CB5LT
• Device Lot Number: L4F636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1