MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC SURGIWAND*II 5MM SUC/IRR W/CAUT/L-HOOK; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)23

Model Number 178091

Device Problems Break (1069); Decrease in Suction (1146); Suction Problem (2170)

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

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the operating room nurse open this product package and gave it to surgeon.The surgeon tried suction but it didn't work well.He found it had problem on the jaw.The jaw was crushed.

Event Description

Additional information provided by the account: procedure; lower anterior resection.Nothing fell into the patient's cavity.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device.The edital tip of the shaft was damaged (indented).The suction and irrigation functions worked properly when the instrument was connected to lab equipment.The instrument passed a leak test with acceptable results.The instrument was submerged in water while connected to a pressurized air hose and no leaks were observed.A review of the device history record could not be performed because the lot number was not provided.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Type of Device: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)23
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5200644
• MDR Text Key: 30619696
• Report Number: 2647580-2015-00773
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K903207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 178091
• Device Catalogue Number: 178091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1