MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCA004L
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
According to the reporter, during the laparoscopically assisted vaginal hysterectomy (lavh) procedure, needle spontaneously dropped during cuff closure and fell into the patient's cavity.The needle was successfully removed with a lap grasper.Two (2) additional new reloads were used on the same endostitch without issue.There was no patient injury involved regarding the event.The device was discarded by the customer.

• Brand Name: V-LOC 180
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6715989
• Report Number: 1219930-2017-05999
• Device Sequence Number: 531377
• Product Code: GAM
• UDI-Device Identifier: 10884521068087
• UDI-Public: 10884521068087
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K111442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2017

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: 12/31/2018
• Device Model Number: VLOCA004L
• Device Catalogue Number: VLOCA004L
• Device Lot Number: N5M0492WX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1