MAUDE Adverse Event Report: ETHICON ENDO LOOP LIGATURE

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/23/2018

Event Type  malfunction  

Event Description

Pt had laparoscopic-assisted total vaginal hysterectomy with bilateral salpingo-oophorectomy on (b)(6) 2018, and on exam on (b)(6) was noted to have retained particles from endostitch.

• Brand Name: ENDO LOOP LIGATURE
• Type of Device: ENDO LOOP LIGATURE
• Manufacturer (Section D): ETHICON
• MDR Report Key: 7709892
• MDR Text Key: 114858798
• Report Number: MW5078508
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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): Other
• Patient Age: 34 YR
• Patient Weight: 82