MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ROTICULATOR 55 POLY; STAPLE, IMPLANTABLE

Model Number	013601
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a hysterectomy, on the cervix, the distal part of the stapler shaft broke.The head of the stapler fell off when trying to close into the patient¿s cavity and all pieces were retrieved.A new stapler was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the cartridge noted the presence of a full complement of retainers and the instrument was fully applied.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.Replication of the observation may occur if the instrument is applied over excessively thick tissue exceeding the recommended tissue range.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ROTICULATOR 55 POLY
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7732474
• Report Number: 1219930-2018-04164
• Device Sequence Number: 1018860
• Product Code: GDW
• UDI-Device Identifier: 20884521047614
• UDI-Public: 20884521047614
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K830199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2019

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: 04/30/2020
• Device Model Number: 013601
• Device Catalogue Number: 013601
• Device Lot Number: N7K0632X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 02/07/2019
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/02/2018; 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1