MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN UNKNOWN LAPRO-CLIP RELOAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN LAPRO-CLIP RELOAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  Injury  

Manufacturer Narrative

Title: absorbable laparoscopic ligating clips: impact on postoperative ct imaging source: t.D.Westwood a, p.Capozzi b, d.F.Martin a, s.A.Sukumar a,* date: received 8 january 2014 received in revised form 21 february 2014 accepted 27 february 2014.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed regarding the impact on postoperative ct imaging of absorbable laparoscopic ligating clips, two weeks following a laparoscopic right hemicolectomy, a series of ct scan was performed and showed that the structure of the clips was easily resolved.Three months postoperatively, the structure of the clips was no longer resolved and inflammatory foreign body reaction predominates which resulted in a 1.5 cm soft-tissue nodule initially mistaken for nodal enlargement.Two years after surgery, a poorly defined residual soft-tissue opacity remains but reduced in size without any treatment, confirming its benign aetiology.

• Brand Name: UNKNOWN LAPRO-CLIP RELOAD
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9035678
• MDR Text Key: 158193605
• Report Number: 1219930-2019-05175
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LAPRO-CLIP RELOAD
• Device Catalogue Number: UNKNOWN LAPRO-CLIP RELOAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention