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 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 4/18/2023.Batch # unk.A manufacturing record evaluation is pending.Additional information was requested and the following was obtained: "did any pieces fall into the patient? if yes, were they retrieved? will all pieces be returned with the device? if no, were they discarded?=>no,currently any pieces did not fall into the patient." 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 by the sales rep that during an unknown procedure, the suture detached when the device was used.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Date sent: 5/10/2023.D4: batch # x95n9l.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the pouch device found that it was received fully deploy.The bag was not returned for analysis.The suture was returned torn.Although no conclusion could be reach on the cause of the reported event.Following precautions should be taken: ( do not attempt to remove the bag with specimen through the trocar as this may lead to bag rupture and spillage of contents.) (care should be taken to avoid contact of the bag with sharp instruments, cutting devices, electrocautery and laser or other instruments.) (excessive forces should be avoided during bag extraction.) as part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

• 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: 16763161
• MDR Text Key: 313524745
• Report Number: 3005075853-2023-02690
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036012986
• UDI-Public: 10705036012986
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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: 973A52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1