MAUDE Adverse Event Report: COVIDIEN BLADELESS VP 8MM ST W/ FIXATION; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number NB8STF

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Event Description

Additional information provided by the account: nothing fell into the cavity.There was no blood loss.The surgical time was extended over 30 minutes.Pneumo-peritoneum was retained throughout the case.The patient had previous abdominal surgeries.The patient had adhesions from previous surgeries.

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: trocar penetrated the urinary bladder.The product was thrown away.The surgeon had a perforated bladder while performing a removal of adhesions and uterine cyst.We have not spoken with the surgeon as of today, however, the tech in the room during the case did provided this information.The surgeon had entered using our 5mm optical bladeless trocar through the umbilicus.She proceeded to place additional trocars under direct visualization, the last being an 8mm covidien bladeless trocar (nb8stf) in a suprapubic port placement.This trocar penetrated and went through the empty bladder.The case proceeded as normal until it came time for specimen removal.Once a 5mm applied bag was deployed and specimen was placed inside, the bag inserter was removed along with the trocar.At this time it was noted that the foley bag began to fill with air.Upon inspection, it was observed that the bladder had been punctured and once the 8mm trocar was removed the defects began to let air into the bag and urine into the abdomen.The bladder was then repaired and case was finished appropriately.It is unknown this time as to the current condition of the patient.At the time the patient was removed from the or she was in good condition.The procedure? 3.What is the patient age, weight, gender, or patient identifier (i.E.Initials or id number, not the full name of the patient)? 4.What is the lot number of the device? if the lot number is unknown, can you provide the lot numbers the account had in stock at the time of the procedure? 5.Did any device component fall into the cavity of the patient? if so, how was it retrieved? 6.Was there blood loss of 500cc or more due to the product problem? a) did any additional blood loss resulting from this product problem require a blood transfusion? 7.Was surgical time extended by more than 30 minutes due to the product problem? a) was any adverse event reported as a result of any delay in surgery? (i.E.An extension of the hospital stay, infection, etc.?) 8.How is the patient doing now? 9.Was pneumo-peritoneum retained throughout the case? 10.Did the patient have any previous abdominal surgeries? 11.Did the patient have adhesions from previous surgeries?.

Manufacturer Narrative

(b)(4).

• Brand Name: BLADELESS VP 8MM ST W/ FIXATION
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4780246
• MDR Text Key: 17936861
• Report Number: 9612501-2015-00251
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB8STF
• Device Catalogue Number: NB8STF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention