MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG ENDO PEANUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	173019
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during surgery a laparoscopic cholecystectomy, endo peanut dissector came apart during use.The radiopaque tip was retrieved and placed together in its original package and taken out of service.All was retrieved.No patient injury was reported.No additional information of the event was provided.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO PEANUT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6610593
• Report Number: 1219930-2017-05689
• Device Sequence Number: 11829
• Product Code: GCJ
• UDI-Device Identifier: 20884523000761
• UDI-Public: 20884523000761
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K931962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 173019
• Device Catalogue Number: 173019
• Device Lot Number: M6L01X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR