MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD UNKNOWN ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Model Number UNKNOWN ENDO CLIP APPLIER

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Perforation (2001); No Code Available (3191)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

Title: randomized controlled trial of monopolar cautery versus clips for staple line bleeding control in roux-en-y gastric bypass source: inonu university, department of gastrointestinal surgery, malatya, turkey; international journal of surgery 58 (2018) 52¿56 published: 2018 ijs publishing group ltd.Published by elsevier ltd.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed november 2016 until november 2017, a total of 169 morbidly obese patients were treated with laparoscopic roux en y gastric bypass.The aim of this study was to compare the clip and monopolar cauterization methods for staple line bleeding control (slbc) in laparoscopic roux-en-y gastric bypass.A total of 489 slbc interventions (274 clips and 215 cauterizations) were performed after 280 stapling applications.Slbc intervention number and location, additional trocar requirement, blood loss and operation time were not different between the groups.No intra-abdominal bleeding or gastrointestinal leakage was seen in any group.There were three postoperative complications and all of them were gastrointestinal bleedings diagnosed with melena and a decrease in hemoglobin level, two in the clip and one in the cautery group.Two patients were treated successfully by conservative methods but a patient in the clip group required laparotomy for a hematoma in the remnant stomach and a perforation at the proximal common limb.After bleeding control, the perforation was repaired primarily and the patient was discharged on the 14th postoperative day.

• Brand Name: UNKNOWN ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9824779
• MDR Text Key: 194775489
• Report Number: 9612501-2020-00448
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENDO CLIP APPLIER
• Device Catalogue Number: UNKNOWN ENDO CLIP APPLIER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 47