MAUDE Adverse Event Report: COVIDIEN POLYSORB 0 VL 5X18 BTP-1 DT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CLT250MG

Device Problem Component Falling (1105)

Patient Problem Injury (2348)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer states: after surgery, they counted the number of the needles and noted the number did not correspond.They looked for the needle, but were not able to find it out.Surgeon decided to close the abdomen as he/she thought the needle had not been contained in the packet from the beginning.However, postoperatively the patient underwent a ct scan to be safe.The event occurred in use for patient.The surgical time was extended by more than 30 min.The status of the patient: no problem.There was no tissue damage.The incision site was not extended.Nothing fell into the patient's cavity.No bleeding occurred.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one device.Visual inspection of the retainer noted that four witness marks were present, while the correct number of units for this product is five; this serves as an indication that the incorrect number of units was placed in the packaging at the time of manufacture.The root cause of the observed condition was determined to be a result of an assembly error.This issue has been brought to the attention of the appropriate manufacturing personnel and a process enhancement has been implemented to prevent this condition from recurring.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: POLYSORB 0 VL 5X18 BTP-1 DT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034928490
• MDR Report Key: 6236227
• MDR Text Key: 64257508
• Report Number: 9612501-2017-00061
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: CLT250MG
• Device Catalogue Number: CLT250MG
• Device Lot Number: D6B2566X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention