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 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown, assumed first day of the year the complaint was reported.Batch # unk.User facility mw # (b)(4).Additional information was requested and the following was obtained: "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".Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16326236
• MDR Text Key: 309075733
• Report Number: 3005075853-2023-00863
• 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
• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1