MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGINEEDLE; PNEUMOPERITONEUM NEEDLE

Model Number	172015
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, at the beginning of surgery for pneumoperitoneum formation, the device was not able to pierce the tissue.The product has been exchange for other device of the same code to complete the procedure.No patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the insufflation needle appeared intact.The device performed normally.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.

• Brand Name: SURGINEEDLE
• Common Device Name: PNEUMOPERITONEUM NEEDLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 8377475
• Report Number: 1219930-2019-01193
• Device Sequence Number: 239759
• Product Code: FHO
• UDI-Device Identifier: 10884521080805
• UDI-Public: 10884521080805
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K863330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 172015
• Device Catalogue Number: 172015
• Device Lot Number: N8D0872X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR