MAUDE Adverse Event Report: COVIDIEN MINI STEP DILATOR AND CANNULA, 5MM SHORT; LAPAROSCOPE, GENERAL AND ACCESSORIES

Catalog Number MS100705

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/02/2016

Event Type  malfunction  

Event Description

Patient in operating room for surgical procedure.While irrigation during diagnostic laparoscopy, 0.5 cm clear plastic piece seen on ovary.Unknown where the piece came from.Removed by surgeon.Per surgeon, the piece of plastic was given to the circulator, saved and sent to pathology.We did not see it at the beginning of the case when we examined the ovaries.The small plastic ring was found towards the end of the case, when we were irrigating.No other foreign objects were found in the abdomen upon survey.From the history obtained, pt has not had other intra-abd procedures (has had cystoscopic/ureteroscopic procedures and egd/colonoscopy).We were not using any laparoscopic instruments that had a plastic ring.Surgeon can think of three possible sources.Since the ring of plastic was found while suctioning/irrigating, it could have been expelled from the inside of the suction irrigator.Another possibility is a piece of the distal segment of one of the plastic step trocar sheaths may have broken off.Another is that the plastic ring may have been in one of the ports and was pushed into the intra-peritoneal cavity when an instrument was introduced.Sent to operating room leadership and central sterile manager for additional input.Per operating room leadership, the piece of plastic certainly looks like it is from one of the plastic trocar sheaths.I asked our general surgery tech specialist, who confirmed my suspicion.The sheathes are disposable, meaning they come from the manufacturer, they are opened directly onto the field, and we throw them away after the case.Our csd department does not process them.They are plastic and cannot be flashed.

• Brand Name: MINI STEP DILATOR AND CANNULA, 5MM SHORT
• Type of Device: LAPAROSCOPE, GENERAL AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 6215665
• MDR Text Key: 63645934
• Report Number: 6215665
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: MS100705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 44