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

Model Number POUCH

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is 2020.Event day and event month were not reported.Investigation summary: the analysis results of the pouch found that only the bag was received for analysis.Upon evaluation, the bag was noted to be torn at the bottom end (not at the seams).The torn portion was noted stretched.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 an attempt to remove the bag with specimen through the trocar or force the bag through the access site, as this may lead to bag rupture and spillage of contents.

Event Description

It was reported that during an unknown procedure, part of the pouch came off during retrieval.Arms did come off but did not fall into patient.Bag did fall off and fell into patient but was retrieved.Specimen was retrieved with another device.Patient consequence was not 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9789422
• MDR Text Key: 200819664
• Report Number: 3005075853-2020-01439
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• 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: T40R9R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1