MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA ORVIL; STAPLE, IMPLANTABLE

Model Number	EEAORVIL21A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic gastric banding procedure, while on gastrojejunostomy, it was difficult to remove the stapler from the cavity.The anvil did not tilt after firing and it was carefully worked out of the anastomoses.It took a few additional minutes to remove the anvil and this resolved the issue.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the orvil cutting ring showed shallow traces of knife impression and the ring was received partially severed.Additionally, cross cutting staple line marks were also observed on the mylar cutting ring.Functional evaluation showed no abnormalities and the anvil tilted after firing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction.The instructions for use manual for this product states: " make certain that the section of tissue to be stapled is free from any metal or similar structure; otherwise, the knife blade may not cut." if information is provided in the future, a supplemental report will be issued.

• Brand Name: EEA ORVIL
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce,pr CT 00716 4401
• MDR Report Key: 7645376
• Report Number: 1219930-2018-03459
• Device Sequence Number: 10794045
• Product Code: GDW
• UDI-Device Identifier: 10884521042841
• UDI-Public: 10884521042841
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K062850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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 Model Number: EEAORVIL21A
• Device Catalogue Number: EEAORVIL21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1