MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	N-2532
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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, intra-operatively during suturing in a laparoscopic procedure, the device needle popped off the suture.A new suture was used to complete the procedure.The patient outcome was asked but unknown.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of eight devices.The visual inspection of the sample noted no sutures and 1 needle.The needle was observed to be detached from the suture.Upon microscopic inspection of the needle, normal needle crimp and swage marks were observed on the needle.A needle attachment test was performed on the sealed samples and the results exceeded the specifications for this product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOSOF
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 6876368
• Report Number: 1219930-2017-07198
• Device Sequence Number: 718842
• Product Code: GAR
• UDI-Device Identifier: 10884521075993
• UDI-Public: 10884521075993
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 01/31/2019
• Device Model Number: N-2532
• Device Catalogue Number: N-2532
• Device Lot Number: A4A1270X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1