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 Problem Abscess (1690)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

Title: a comparison of absorbable polymetric clips and metallic clips in laparoscopic appendectomy.Source: j med sci 2023;43 (2):63-66 ting-yuan feng, sheng-chun wang, guo-shiou liao, teng-wei chen, de-chuan chan, kuo-feng hsu, journal of medical sciences (taiwan), 10.4103/jmedsci.Jmedsci_372_21 d10 concomitant product: unk laprocl rel, unknown lapro-clip reload (lot#unk).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed between june 2020 and may 2021, a retrospective study evaluated outcomes in patients who underwent laparoscopic appendectomies between (b)(6) 2020 and (b)(6) 2021.Appendicular stump and appendiceal closure was performed with absorbable ligating clip applier in 59 patients and another clip applier was used in 61 patients.One patient in each group developed intra-abdominal abscesses that required prolonged drainage and longer hospital stay.Other complications that were not related to the device included: ileus and surgical site infection.

• 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 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17289033
• MDR Text Key: 318918943
• Report Number: 9612501-2023-01142
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/10/2023
• 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
• Treatment: PLEASE SEE NOTE ON H10
• Patient Outcome(s): Required Intervention; Hospitalization