MAUDE Adverse Event Report: COVIDIEN LP E2781R-28ASP OPTI4 CURVED SPAT; ES ACCESSORY

Model Number E2781RS

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

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

Event Date 12/17/2014

Event Type  malfunction  

Event Description

The customer reported that while inserting the device during a laparoscopic cholecystectomy, it was noted that the tip was broken.The surgeon determined that since the tip was broken prior to insertion, the broken part did not fall into the patient cavity.The broken piece was not located.It was also reported that the device had been opened and then sterilized prior to the procedure even though it wasn't reused.The customer stated the damage may have occurred during the sterilization process.Any relation of a failure in the product is not suspected as a cause of the event.N process.Any relation of a failure in our product is not suspected as a cause of this event.

Manufacturer Narrative

(b)(4).Date of initial report: 02/05/2015.The return of the incident sample has been requested.To date, it has not been received for evaluation.Additional questions in regard to the incident have been asked.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).Date of initial report: 02/05/2015.Date of follow-up report: 03/10/2015.Evaluation of the incident device confirmed the insulation near the spatula tip was brittle and deteriorating.The insulation was broken 1/2 inch from the end of shaft all the way around the tube.It is unknown if resterilization by the site caused or contributed to the damage.The cause of the damage could not be determined.

• Brand Name: E2781R-28ASP OPTI4 CURVED SPAT
• Type of Device: ES ACCESSORY
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; 2034925267
• MDR Report Key: 4486636
• MDR Text Key: 5348465
• Report Number: 1717344-2015-00083
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: E2781RS
• Device Catalogue Number: E2781RS
• Device Lot Number: 42360018X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2014
• 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