MAUDE Adverse Event Report: COVIDIEN LP SPACEMAKER; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number SMSBTOVLX

Device Problem Break (1069)

Patient Problem Hernia (2240)

Event Date 06/06/2019

Event Type  malfunction  

Event Description

Inner obturator broke in half when surgeon removed it from trocar.Preoperative diagnosis: right inguinal hernia.Incarcerated umbilical hernia postoperative diagnosis: right inguinal hernia.Incarcerated umbilical hernia procedure: laparoscopic repair of right inguinal hernia.Open repair of incarcerated umbilical hernia.Description of procedure: dissection down through the subcutaneous tissues was carried out using s retractors in a blunt fashion down to the anterior rectus sheath.We then made a transverse incision in the fibers of the anterior rectus sheath using an 11 blade, and then used metzenbaum scissors to widen this to about a cm and a half.We then identified the medial edge of the rectus muscle.I was able to place my finger into the retrorectus space and sweep this around.We then placed a kidney-shaped dissecting balloon down in the pubic symphysis and inflated this under optical guidance.There were no complications noted from inflation of this device.We then placed a structural balloon after removing the dissecting balloon and placed the patient in trendelenburg position.The preperitoneal space was then insufflated to a pressure of 15 mmhg.The 10 mm 30-degree camera was inserted and the preperitoneal space inspected.There was no bleeding or any other complications noted.Two lower midline 5 mm ports were placed under direct vision.The right groin was dissected out first.The preperitoneal space was dissected back to the level of the aortic bifurcation.A small to moderate indirect hernia was noted.A 15 x 10 cm piece of mesh that was anatomically shaped was folded, marked, moistened and inserted.It was then deployed, centering it on the hernia defect.The mesh laid nicely in place.We did a limited dissection on the opposite side, examining the direct and indirect spaces as well as the femoral spaces.There were no hernias noted on the opposite side.We then slowly desufflated the preperitoneal space.The mesh stayed nicely in place.A completion laparoscopic survey was performed.There were no complications noted.

• Brand Name: SPACEMAKER
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8926226
• MDR Text Key: 155376441
• Report Number: 8926226
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521545311
• UDI-Public: (01)10884521545311(17)200831(10)P8H1165X
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMSBTOVLX
• Device Catalogue Number: SMSBTOVLX
• Device Lot Number: P8H1165X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA