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

Model Number POUCH

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.

Event Description

It was reported that during a laparoscopic cholecystectomy, the bag popped and tore.The bag tore easily and user reports they have never had this issue before.All components of the bag were retrieved from the patient.Surgeon was able to get the gall bladder out with this pouch.The procedure was completed with no patient consequences.

• 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: 10805001
• MDR Text Key: 215346976
• Report Number: 3005075853-2020-05835
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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: U4087N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1