MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGITIE; SUTURE, ABSORBABLE, NATURAL

Model Number	EL-21-L
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, postoperatively, of an laparoscopic appendectomy procedure, when the device used to close the appendix, t here was a release or the loops loosened for the three synthetic ligature loops due to the appendectomy, which resulted in peritonitis.It was noted that it was very painful for the patient.To resolve the issue, additional surgery for closure of the appendicular stump was done by stapling.
Additional Manufacturer Narrative
D10 concomitant product: el-21-l - el-21-l polysorb* 0 vio 52cm tie wdx6, lot# j3g2671y el-21-l - el-21-l polysorb* 0 vio 52cm tie wdx6, lot# j3g2671y medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, 2 days postoperatively, of an laparoscopic appendectomy procedure, when the device used to close the appendix, there was a release or the loops loosened for the three synthetic ligature loops due to the appendectomy, which resulted in peritonitis.It was noted that it was very painful for the patient.To resolve the issue, additional surgery for closure of the appendicular stump was done by stapling.

• Brand Name: SURGITIE
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• 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: 19117676
• Report Number: 9612501-2024-00983
• Device Sequence Number: 7558879
• Product Code: GAL
• UDI-Device Identifier: 10884521099630
• UDI-Public: 10884521099630
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K904588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: EL-21-L
• Device Catalogue Number: EL-21-L
• Device Lot Number: J3G2671Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/12/2024
• Date Device Manufactured: 07/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown