MAUDE Adverse Event Report: ADVANCED SURGICAL CONCEPTS (ASC) OLYMPUS PNEUMOLINER CONTAINED DEVICE; CONTAINMENT SYSTEM, LAPAROSCOPIC POWER MORCELLATION WITH INSTRUMENT PORT

Model Number WA90500US

Device Problems Material Puncture/Hole (1504); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  Injury  

Event Description

During a robotic assisted laparoscopic myomectomy, bilateral salpingo-oophorectomy a lina morcellator and an olympus contained extraction system was used for removing the fibroids from the abdomen.The vendor rep provided the olympus contained extraction system from his stock.During the procedure it was noted that the extraction system liner had a hole in it from the morcellator cutting the bag with the fibroid tissue.The bag was inspected and appeared to have a small 1-2 mm piece missing.Fda safety report id# (b)(4).

• Brand Name: OLYMPUS PNEUMOLINER CONTAINED DEVICE
• Type of Device: CONTAINMENT SYSTEM, LAPAROSCOPIC POWER MORCELLATION WITH INSTRUMENT PORT
• Manufacturer (Section D): ADVANCED SURGICAL CONCEPTS (ASC)
• MDR Report Key: 9348814
• MDR Text Key: 167329872
• Report Number: MW5091187
• Device Sequence Number: 1
• Product Code: PMU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/18/2019

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 Expiration Date: 05/05/2020
• Device Model Number: WA90500US
• Device Lot Number: 113202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 67