MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ROTICULATOR ENDO DISSECT* 5MM INSTRUMENT; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number 174213

Device Problem Failure to Cut (2587)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

Ftr# (b)(4).Patient information not provided.Phone number: not provided.Additional information has been requested, but not yet received.

Event Description

According to the reporter, during a laparoscopic cholecystectomy procedure, the product was used with monopolar cautery, but did not cauterize, which created a defect in the tissue.There was bleeding because there was no connection with the cautery.To correct this condition, another product was opened.The bleeding first part was burned.Tissue damage was seen.There was unanticipated tissue loss.

Manufacturer Narrative

(b)(4).

Event Description

Additional information provided: "bleeding has been in part because there was not connection with cautery.Another product was opened.Bleeding first part was burned.".

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual and functional testing noted no abnormalities.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.Based on the evidence available, the reported condition was not confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic cholecystectomy procedure, the product was used with monopolar cautery, but did not cauterize, which created a defect in the tissue.There was bleeding because there was no connection with the cautery.To correct this condition, another product was opened.The bleeding first part was burned.Tissue damage was seen.There was unanticipated tissue loss.

• Type of Device: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• 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: 6273988
• MDR Text Key: 65622653
• Report Number: 2647580-2017-00081
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K914753
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 174213
• Device Catalogue Number: 174213
• Device Lot Number: P5D461X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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): Other
• Patient Age: 48 YR
• Patient Weight: 79