SURGINEEDLE
Received Feb 28, 2019 · Event occurred Jan 28, 2019
Report 1219930-2019-01193 · MDR key 8377475
Device
Generic name
Pneumoperitoneum Needle
Manufacturer
Covidien Lp Llc North HavenModel number
172015Catalog number
172015
Lot number
N8D0872X
Product problems
- Difficult or Delayed Positioning
- Difficult or Delayed Positioning
Patient
13 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
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.