MAUDE Adverse Event Report: PETERS SURGICAL TLIFT®; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number AW16280

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

Ope triage personnel received a call from doctor concerning a surgery he performed while using a faulty piece of equipment.He states that he was using a t'lift singe-use laparoscopic retraction system which is used to go through the abdominal wall to hold the ovary out of the way for surgery.Doctor says it deploys like an iud and when he used it, a piece of the equipment was broken off and discharged into the abdomen.It was about the size of 3mm-1mm, and it was recognized right away.They searched for the piece but was unable to locate it.Since the device is not radiopaque, the surgeon was unable to locate this piece and was forced to close with it inside.Doctor disclosed this to the patient's relative right after surgery but the patient was asleep, and patient has not had a conversation with their significant other.Doctor did answer all the questions and concerns that the patient's significant other had at the time.The or manager is aware according to his statement.

• Brand Name: TLIFT®
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): PETERS SURGICAL; 10 cordage park cir # 100; plymouth MA 02360
• MDR Report Key: 16245649
• MDR Text Key: 308155576
• Report Number: 16245649
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2023,01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AW16280
• Device Catalogue Number: AW16280
• Device Lot Number: B21140D
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Sex: Female
• Patient Weight: 101 KG