MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON SNGL LAPRO-CLIP 12MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 8886848813

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Impaired Healing (2378); Foreign Body In Patient (2687)

Event Date 05/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information has been requested but not yet received.A supplemental will be submitted upon receipt of any new information.

Event Description

According to the reporter: the patient underwent a cholecystectomy procedure.The patient appeared poi with abdominal pains five days after the operation.The patient left the hospital and received a wound dressing at a different hospital, however, this did not work.The patient returned to the original hospital twenty five days post procedure.The biliary fistula was checked.The patient underwent a second operation and the surgeon checked the surgical drainage.Broken clip was found in the drainage fluid.

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: additional information received from the account stated that the clips were being used for a bile duct occlusion.Two clips were applied.Both clips were found to be broken into small pieces.The broken clips did not cause any tissue damage.The patient is currently fine.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one photo of a device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device.The visual inspection of the photo noted a clip in multiple pieces.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.Based on the evaluation of the photo the root cause of the observed condition could not be reliably determined; however, based on observations the most likely root cause for the observed condition was determined to be thick tissue application.The file will be closed as could not be reliably determined.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: SNGL LAPRO-CLIP 12MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5798471
• MDR Text Key: 49676076
• Report Number: 1219930-2016-00733
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N5M0743EX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/22/2016; 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 70