MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EXTRA VIEW; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	OMS-XB2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic bilateral inguinal hernia repair, the balloon physically broke.There was no patient injury.
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.
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 the balloon was disengaged from the cannula.The protective sheath for the balloon was attached to the cannula.The obturator was received and intact.The insufflation bulb was received.It was reported that the disengaged balloon from the cannula.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when excessive air is applied during clinical application.The received unit condition could happen when excessive force is applied to the frontal area of the balloon already inflated.This pressure makes the inner flange to detach from the inner sleeve.The degree of damage can go from separating to flange making the unit leak to fully separate the flange, making the balloon to fully deflate immediately.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: use proper inflation volume of balloon using included syringe.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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the balloon was disengaged from the cannula.The protective sheath for the balloon was attached to the cannula.The obturator was received and intact.The insufflation bulb was received.Functionally, the converter doors moved freely and were secured in place.It was reported that the balloon was broken.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: of the balloon was disengaged from the cannula.The product analysis noted evidence that the device was not used as intended.This issue may occur when excessive air is applied during clinical application.The received unit condition could happen when excessive force is applied to the frontal area of the balloon already inflated.This pressure makes the inner flange to detach from the inner sleeve.The degree of damage can go from separating to flange making the unit leak to fully separate the flange, making the balloon to fully deflate immediately.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: use proper inflation volume of balloon using included syringe.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: EXTRA VIEW
• Common Device Name: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20470816
• Report Number: 2647580-2024-04448
• Device Sequence Number: 12665604
• Product Code: GCJ
• UDI-Device Identifier: 10884521068032
• UDI-Public: 10884521068032
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K954175
• 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): 01/28/2025

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: 05/31/2026
• Device Model Number: OMS-XB2
• Device Catalogue Number: OMS-XB2
• Device Lot Number: P3F0073
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 01/27/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 01/17/2025; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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
• Patient Sex: Unknown