MAUDE Adverse Event Report: US SURGICAL PUERTO RICO UNKNOWN SPACEMAKER BALLOON; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN SPACEMAKER BALLOON

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

Patient Problems Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446)

Event Date 03/12/2021

Event Type  Injury  

Event Description

According to the literature, a prospective study compared outcomes of balloon dissection (bd) and camera dissection (cd) for 40 patients undergoing totally extraperitoneal repair (tep).The balloon dissector was used with the following complications: hemorrhage and wound infection.Interventions not discussed.Article: the comparison of balloon and camera dissection of the preperitoneal space in totally extraperitoneal repair hernia repair.Author: selim birol year: 2021, publication: sage publishing.

Manufacturer Narrative

Title: the comparison of balloon and camera dissection of the preperitoneal space in totally extraperitoneal repair hernia repair.Our initial experience source: surgical innovation 2021, vol.28(6) 695¿699 © the author(s) 2021 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/1553350621999297, journals.Sagepub.Com/home/sri.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN SPACEMAKER BALLOON
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13387299
• MDR Text Key: 284681132
• Report Number: 2647580-2022-00313
• Device Sequence Number: 1
• Product Code: GCJ
• 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,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SPACEMAKER BALLOON
• Device Catalogue Number: UNKNOWN SPACEMAKER BALLOON
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2022
• 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): Other