MAUDE Adverse Event Report: US SURGICAL PUERTO RICO STEP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number S100705

Device Problems Break (1069); Material Fragmentation (1261); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic thoracoscopy, upon inserting the camera through the port, debris was seen inside the thoracic cavity.Pieces of debris were successfully removed, but as the camera or other instruments continued to be inserted through the port, more debris was noted.It was decided by the doctors that the debris was coming from the port so it was removed from the patient.As the camera was removed, it appeared that the inside of the port's cannula was "ripped up" and that is where the pieces or debris were coming from.Any debris visualized during the thoracoscopy were removed by the doctor and his team to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) received one device.The visual inspection of the returned products noted that the devices were received unopened in its original packaging.Pmv performed functional testing; the devices passed an air leak test.All other components functioned properly.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7700904
• MDR Text Key: 114705278
• Report Number: 2647580-2018-03591
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521090658
• UDI-Public: 20884521090658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: S100705
• Device Catalogue Number: S100705
• Device Lot Number: P8B0861X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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: 14 YR