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

Model Number 8886848813

Device Problems Device Slipped (1584); Failure to Form Staple (2579)

Patient Problem Blood Loss (2597)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter phone number: (b)(6).

Event Description

According to the reporter, during a laparoscopic cholecystectomy, the clip slid off and did not close properly.There was strong bleeding 1-1, 5 l, bleeding could be stopped.To correct the problem and stop the bleeding, a titan clip was set.The procedure was extended 70 minutes, but there was no adverse event due to this delay.The blood loss was not more than 500ccs.Patient is well and already discharged from the hospital.

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation 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.Visual inspection of the open cartridge noted it was received not applied and one fully formed clip was received.Seven sealed units were received with no visual abnormalities.A pmv representative instrument was used for all functional testing.The cartridges were loaded into the pmv representative instrument and the firing handle was actuated.The clips were found to form properly onto the test media.Engineering determined that the tracks out of alignment were acceptable.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.Therefore, the investigation was unable to establish a relationship between the device and the reported incident.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: 6068096
• MDR Text Key: 58815184
• Report Number: 1219930-2016-01135
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2016

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: 05/31/2021
• Device Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N6E0463X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/13/2016; 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention