MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON 45 MM STAPLER; STAPLER, SURGICAL

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

Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 06/24/2019

Event Type  Injury  

Event Description

Procedure performed: laparoscopic left radical nephrectomy with partial ureterectomy and lysis of adhesions (complicated procedure due to prior abdominal surgery with intra-abdominal adhesions) and retroperitoneal lymph node dissection lysis of intra-abdominal intestinal adhesions.Bleeding occurred postop, ccat called morning of pod#1, pt transferred to icu as he was unstable, hgb drop from 19 to 14 within 12-14 hours postop.Had large retroperitoneal bleed.Fda safety report id# (b)(4).

• Brand Name: ETHICON 45 MM STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 8888335
• MDR Text Key: 154257323
• Report Number: MW5088965
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR