MAUDE Adverse Event Report: COVIDIEN SPACEMAKER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SMSBTOVLX
Medical Device Problem Codes	Inflation Problem (1310); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
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
It was reported that during setup of the balloon trocar for a laparoscopic inguinal hernia repair, the surgeon put the balloon into the cavity, user released the balloon did not expand, the surgeon wanted to control the balloon he released that the tip of the number 2 trocar was broken, that's why the balloon did not expand.The issue was resolved by opening a new device to complete the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the first image depicts the dissector hub detached from the cannula.The second image depicts a close-up view of the detached hub and cannula.The third image depicts a different angle view of the detached hub and cannula with the balloon not inflated.The trocar balloon was intact.The dissector balloon and cannula were disengaged from the hub, material transfer was noted.The insufflation bulb was received.The inflation syringe was not received.The short obturator was received.The long obturator was not received.The ports and 5mm obturator were not received.Functional testing found that the dissector balloon could not be inflated due to the damage in which it was received.The trocar balloon was inflated using a test syringe, no leaks detected.The lock collar move up and down the cannula freely and securely locked in place.It was reported that the balloon did not inflate and cannula detached from hub.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when care is not exercised during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: balloon products must be treated with care.Damage to balloons from instruments during the procedure may cause product failure.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
Correction: h3 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the first image depicts the dissector hub detached from the cannula.The second image depicts a close-up view of the detached hub and cannula.The third image depicts a different angle view of the detached hub and cannula with the balloon not inflated.The trocar balloon was intact.The dissector balloon and cannula were disengaged from the hub, material transfer was noted.The insufflation bulb was received.The inflation syringe was not received.The short obturator was received.The long obturator was not received.The ports and 5mm obturator were not received.Functional testing found that the dissector balloon could not be inflated due to the damage in which it was received.The trocar balloon was inflated using a test syringe, no leaks detected.The lock collar move up and down the cannula freely and securely locked in place.It was reported that the balloon did not inflate and cannula detached from hub.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when care is not exercised during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: balloon products must be treated with care.Damage to balloons from instruments during the procedure may cause product failure.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 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24257380
• Report Number: 2647580-2026-00277
• Device Sequence Number: 12843740
• Product Code: GCJ
• UDI-Device Identifier: 10884521545311
• UDI-Public: (01)10884521545311(17)260228(10)P4C0954(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Followup,Followup
• Report Date (Section B): 04/29/2026

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 Expiration Date: 02/28/2026
• Device Model Number: SMSBTOVLX
• Device Catalogue Number: SMSBTOVLX
• Device Lot Number: P4C0954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/16/2026; 04/16/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/29/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown