MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC SHORT 5MM CANNULA/DILATOR W/RAD EXPD SLV; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number S100705

Device Problems Air Leak (1008); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2015

Event Type  malfunction  

Event Description

Procedure: laparo appendectomy.According to the reporter: in ten minutes from the operation, air leaked as a trocar valve broke.Opened another.Surgeon found it immediately, so nothing fell into the cavity.No a keen forcep was used.Tissue damage: no.No bleeding.The seal of the trocar broke in this case.

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: the seal of the trocar broke.

• Brand Name: SHORT 5MM CANNULA/DILATOR W/RAD EXPD SLV
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4810371
• MDR Text Key: 5830159
• Report Number: 2647580-2015-00404
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: S100705
• Device Catalogue Number: S100705
• Device Lot Number: P4G0749X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1