MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD UNKNOWN TROCAR DEVICE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN TROCAR DEVICE

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

Patient Problems Abdominal Pain (1685); Vomiting (2144); Obstruction/Occlusion (2422)

Event Date 10/28/2021

Event Type  Injury  

Event Description

According to the literature, a (b)(6) year-old woman underwent laparoscopic salpingo-oophorectomy.A 10millimeter bladeless optical trocar was used in the lower abdominal quadrant.None of the port sites had been stretched.On the fifth postoperative day, patient was presented to the emergency department with the following symptoms of intestinal obstruction: persistent abdominal pain, vomiting, and inability to pass stool or flatus.A computed tomography showed a herniated loop of small bowel through the lower abdominal trocar entry site.The patient underwent surgery to resolve the issue and a bowel resection was not necessary.The patient recovered well and was discharged 10 days later.Article: trocar-site hernia following laparoscopic salpingo-oophorectomy in a middle-aged japanese woman: an initial case report after 40 years of experience at a single center and a brief literature review author: kuniaki ota year: 2022 publication: bmc women¿s health.

Manufacturer Narrative

Title: trocar-site hernia following laparoscopic salpingo-oophorectomy in a middle-aged japanese woman: an initial case report after 40 years of experience at a single center and a brief literature review source: ota et al.Bmc women¿s health (2022) 22:8 accepted: 28 october 2021.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN TROCAR DEVICE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13693352
• MDR Text Key: 286766417
• Report Number: 9612501-2022-00359
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN TROCAR DEVICE
• Device Catalogue Number: UNKNOWN TROCAR DEVICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2022
• 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
• Patient Age: 41 YR
• Patient Sex: Female