MAUDE Adverse Event Report: COVIDIEN LP PDB; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number OMS-PDB1000

Device Problems Material Rupture (1546); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

When the balloon was inflated inside the patient, it popped.The pop was audible to people in the room, all pieces were retrieved (2 pieces total) and saved for an event report.Surgeon reported that a few seconds, exact amount unknown, after balloon inflation the audible pop was heard.New device was obtained and functioned well without issue.

• Brand Name: PDB
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10939970
• MDR Text Key: 219338205
• Report Number: 10939970
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521067929
• UDI-Public: (01)10884521067929(17)201231(10)P7M1132X
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2020

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
• Device Operator: Health Professional
• Device Model Number: OMS-PDB1000
• Device Catalogue Number: OMS-PDB1000
• Device Lot Number: P7M1132X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Weight: 107