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

Model Number POUCH

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic sleeve gastrectomy procedure; "the endo batch bag string broke during surgical case when attempting to close the bag.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch # unk.Additional information was requested and the following was obtained: "when pulling on the green string to tighten the pouch, the string breaks.He used 4 endocatches on this specific day and 3 out of the 4 had this issue.Where any patient consequences? if yes, please describe¿no pt.Harm but did prolong surgical procedure" "it was initially reported for (b)(4) that this has happened on 2 other cases previously.(b)(4) and (b)(4) created to capture those 2 events.Of which i have no additional information on these additional two events.In previously received additional event information it was stated that, "3 of the 4 devices that day did not work".Were all 4 of these devices used in one procedure, or is this the total devices used for all 3 events? i do not have that information and since this event happened a while ago i will not be able to ask the surgical team.If these 4 were for one procedure, please clarify how many devices were used for each of the other related events (b)(4) unable to answer this detail for all 3 events could you please answer the following questions: (b)(4): did any contents spill into the patient? unable to answer this detail if so, was it retrieved? unable to answer this detail was pouch removed through trocar or through abdominal port site? unable to answer this detail were there any changes to the procedure or post op care of the patient related to the pouch breaking? unable to answer this detail" an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

Manufacturer Narrative

(b)(4).Date sent: 2/8/2023.Maude report number: (b)(4).E4.Reporter also sent report to fda? yes.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16324665
• MDR Text Key: 309077169
• Report Number: 3005075853-2023-00851
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036012986
• UDI-Public: 10705036012986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: POUCH
• Device Catalogue Number: POUCH
• Device Lot Number: 895A27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Hispanic