MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DBD-GASTRIC SLEEVE

Catalog Number DYNJ903460J

Device Problem Failure to Form Staple (2579)

Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported, that during a laparoscopic sleeve gastrectomy procedure, the surgeon while using a tri-stapler, the device malfunctioned and did not staple all the way which caused a hole in the staple line, which led to a leak in a patient's stomach.The reporter states, "the hole was laparoscopically sewn closed, which extended the procedure and general anesthesia time by approximately 20 minutes.Due to the reported medical intervention.This medwatch is being filed.The sample item has not been returned.Therefore, a root cause cannot be determined.There is no further information at this time.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported, "a tri-staple reload did not staple all the way which caused a hole in the staple line which led to a leak in a patient's stomach." the hole was laparoscopically sewn closed.

• Type of Device: DBD-GASTRIC SLEEVE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10347504
• MDR Text Key: 202374531
• Report Number: 1423395-2020-00019
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ903460J
• Device Lot Number: N9H0325Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 138