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

Catalog Number POUCH

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event year known: 2018.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that during an unknown procedure the endopouch seemed smaller and of different material.The pouch broke during use.A second like device 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7476913
• MDR Text Key: 107211785
• Report Number: 3005075853-2018-09475
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036012983
• UDI-Public: 20705036012983
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: POUCH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1