MAUDE Adverse Event Report: ETHICON ENDO-SURGERY INC ETHICON ENDOPUCH RETRIEVER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Lot Number U4051A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  Injury  

Event Description

Two ethicon endopouch malfunctioned during a procedure.With the first pouch, the metal came out of the bag.With the second endopouch the suture broke on the bag making it difficult to remove.The endopouch was removed with no harm to the patient.Fda safety report id# (b)(4).

• Brand Name: ETHICON ENDOPUCH RETRIEVER
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY INC; blue ash OH 45242
• MDR Report Key: 10600043
• MDR Text Key: 209154350
• Report Number: MW5096920
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: U4051A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR