MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPOUCH RETRIEVER SPEC BAG; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number POUCH

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Additional information: four photos were received for review and photo review is in progress.When review has been completed, a supplemental medwatch will be sent with additional information regarding findings from photo review.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being made to obtain the following information and the device.To date, no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: was remnant sleeve comfortably positioned in pouch? could they close pouch prior to removal? what is surgeon experience with pouch device? was trocar site/fascial incision enlarged prior to removal of pouch? was it noticed if pouch was stretched prior to breaking?.

Event Description

It was reported that pouch device was used to contain stomach remnant in sleeve gastrectomy procedure.Pouch was used to remove remnant out through trocar incision and during removal, pouch was grasped by hand and force applied to remove.Pouch split due to the force applied, and appeared to produce fragments.Surgery was delayed by ten minutes a they tried to piece the pouch together to understand the magnitude of fragments.The patient abdominal cavity was also searched for fragments but is unknown if they were able to retrieve all fragments of pouch.Surgery was successfully completed.Patient consequence was reported as unknown and current patient status was reported as unknown.

Manufacturer Narrative

(b)(4).Date sent: 10/29/2020.H2: additional information received: four photos were received for review.Upon visual inspection of the four photos, the following was observed: the photos show a loose bag and the bag was noted to be torn at the bottom end.Based on the photos, no conclusion could be reached as to what may have caused the reported incident.The assignable cause of the reported complaint could not be determined.Hands on device analysis may have provided the additional evidence necessary to confirm the root cause of the reported event, however no device was received for analysis.Also, additional information was requested and the following was obtained: was remnant sleeve comfortably positioned in pouch? yes, they leave the tip of the stomach protruding from the pouch so that when the pull up through the trocar incision they can grasp the stomach to apply pulling force to the stomach and minimize pressure/pull force on the pouch.Could they close pouch prior to removal? yes.What is surgeon experience with pouch device? this was a fellow so probably 8 months experience with this technique, supervising surgeon has many years experience.Was trocar site/fascial incision enlarged prior to removal of pouch? yes; they insert scissors into the port site and open using the force of the scissors to expand facial defect.Was it noticed if pouch was stretched prior to breaking? yes, there was some tension applied to the pouch.

• Brand Name: ENDOPOUCH RETRIEVER SPEC BAG
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10594001
• MDR Text Key: 208799429
• Report Number: 3005075853-2020-04957
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036012986
• UDI-Public: 10705036012986
• Combination Product (y/n): N
• PMA/PMN Number: K011501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: POUCH
• Device Catalogue Number: POUCH
• Device Lot Number: U4073D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other