MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X100MM STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number 2CB5LT

Device Problem Device Slipped (1584)

Patient Problems Hernia (2240); No Code Available (3191)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.As a lot/batch was not provided, a device history could not be performed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the current patient status? what was the approximate size of the incision made? were there any difficulties inserting the trocar? is it the "surgeon" normal routine to close the fascia of the trocar port? did the surgeon close the fascia of the trocar port where the hernia was? what was the anatomical position of this port? was an intra-abdominal laparoscope used to look at the fascia defect prior to completing the case? what instruments were used in the trocar port were the slipping issue occurred?.

Event Description

It was reported that during a laparoscopic hysterectomy with bilateral salpingo oophorectomy procedure that the trocar kept slipping out of the patient and because he kept having to put it back in.The abdominal wall defect got larger and the patient came back with a hernia.Patient was re-operated on (b)(6) 2018.Patients status is currently unknown.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: the sales rep responded that she was able to answer some of the questions.Please see below.She has spoken to the surgeon twice about this and he has mentioned that he does not want to answers questions or speak with anyone further regarding this.What is the current patient status? what was the approximate size of the incision made? diameter equal to size of trocar cannula.Were there any difficulties inserting the trocar? no.Is it the surgeon normal routine to close the fascia of the trocar port? did the surgeon close the fascia of the trocar port where the hernia was? what was the anatomical position of this port? was an intra-abdominal laparoscope used to look at the fascia defect prior to completing the case? yes.What instruments were used in the trocar port were the slipping issue occurred? harmonic, graspers.

• Brand Name: OPT SLEEVE 5X100MM STABILITY
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8043312
• MDR Text Key: 126304748
• Report Number: 3005075853-2018-14201
• Device Sequence Number: 0
• Product Code: GCJ
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2CB5LT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 11/20/2018
• Patient Sequence Number: 1