MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIG PDS II VIO SUT; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number EZ10C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported by the patient that she underwent an elective procedure, laparoscopic cholecystectomy and intraoperative cholangiogram under general anesthetic on unknown date and the suture ligature system was used.Later in a subsequent laparoscopic surgery a surgeon found and removed a ¿30cm foreign object¿ from the patient¿s abdomen.Following the investigation process there was reasonable evidence to identify the alleged foreign object to be a suture plastic ¿sheath¿ used during the elective procedure.The patient stated that she was extremely stressed about the incident and had, ¿always felt a little off since then.¿ no further information is available.

• Brand Name: ENDOLOOP LIG PDS II VIO SUT
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12770894
• MDR Text Key: 284679185
• Report Number: 2210968-2021-11032
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K843187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EZ10C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female