MAUDE Adverse Event Report: Covidien Spacemaker; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SMBTTRNDX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic inguinal total extraperitoneal (tep) procedure, the two dissecting balloons were inflated during dissection, and the balloons ruptured.Dissection could not be performed with the original balloon, and plastic balloon frag ments fell into the patient cavity.An inspection was performed to remove the plastic fragments.It was also mentioned that the balloon that needed to inflate had a dull color.Surgical time was extended by 30 minutes or more.To resolve the issue, dissection was completed with another balloon until adequate space was created.
Additional Manufacturer Narrative
D10 concomitant products: spacemaker, spacemaker pro btt + round (lot # p6b0944); spacemaker, spacemaker pro btt + round (lot # p6b0944); spacemaker, spacemaker pro btt + round (lot # p6b0944); spacemaker, spacemaker pro btt + round (lot # p6b0944).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.

• Brand Name: Spacemaker
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): Covidien; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer (Section G): Covidien; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50455666
• Report Number: 2647580-2026-02559
• Device Sequence Number: 16062542
• Product Code: GCJ
• UDI-Device Identifier: 10884521545304
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K151356
• 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
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SMBTTRNDX
• Device Catalogue Number: SMBTTRNDX
• Device Lot Number: P6B0944
• 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: 08/11/2026
• Initial Report FDA Received Date: 08/26/2026
• Date Device Manufactured: 02/24/2026
• 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
• Patient Sex: Unknown