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

Catalog Number POUCH

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t9422g.Investigation summary: the analysis results confirmed that the pouch device was returned fully deployed and with the suture torn.A sample bag was returned detached.Upon evaluation, the bag was noted to be torn at the bottom end (not at the seams).The torn portion was noted to be stretched.In order to evaluate the internal components, the device was disassembled.Upon disassembly of the device, no anomalies were noted with the internal components.Each device is 100% visually inspected prior to shipment and damage of this magnitude would have been detected during this inspection.However, a potential cause of the torn bag is attempting to remove the bag, with specimen, through the trocar or by forcing the bag through the access site as this may lead to bag rupture and spillage of contents.A manufacturing record evaluation was performed for the finished device batch number and no non-conformances were identified.

Event Description

It was reported that during a laparoscopic cholecystectomy, during the specimen removal, the bag broke as they were pulling it out of the abdomen.A second like pouch was used to complete the procedure.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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9399148
• MDR Text Key: 197789393
• Report Number: 3005075853-2019-23918
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: POUCH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1