MAUDE Adverse Event Report: PETERS SURGICAL T'LIFT; SINGLE-USE RETRACTION SYSTEM

Model Number AW16280

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the batch records for the t'lift retraction system batch n°b21140d has been performed.All results of controls performed are found compliant to their specifications, including results on the injection of the component broken.No non-conformity has been detected during the manufacturing of the batch.To date, no other incident has been reported with the batch n° b21140d of t'lift.Additional tests have been conducted on 3 retained samples of the incriminated batch of t'lift.The resistance of the t'lift to a load have been found compliant to the specification.To date, the incriminated device has not been returned by the healthcare facility to complete the investigation therefore the root-cause cannot be established.

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.What was the original intended procedure? : laparoscopic hysterectomy.What problem did the user have (check all that apply) :device malfunction - that is, the device did not do what it was supposed to do; device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: T'LIFT
• Type of Device: SINGLE-USE RETRACTION SYSTEM
• Manufacturer (Section D): PETERS SURGICAL; immeuble aurelium; 1 cours de l'ile seguin; boulogne-billancourt, 92100 ; FR 92100
• Manufacturer (Section G): PETERS SURGICAL; zone industrielle bioparc; hauterive, allier 03270 ; FR 03270
• Manufacturer Contact: sébastien guillo ; immeuble aurelium; 1 cours de l'ile seguin; boulogne-billancourt, 92100 ; FR 92100
• MDR Report Key: 16415838
• MDR Text Key: 309945444
• Report Number: 3005459904-2023-00001
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 03700393301360
• UDI-Public: 03700393301360
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 101 KG