MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Catalog Number	TLH30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/7/2018.Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Is the patient still in the hospital? if yes, iis this due to alleged device malfunction? was the extended hospital stay planned due to the type of procedure or patient pre-existing condition prior to the procedure?.
Event or Problem Description
It was reported that during the radical resection of lung cancer, when severing the bronchus, after fired, found one of staple line was malformed with irregular shape.Bronchus had leakage, suture was used to sew the wound.The surgery delayed about 15 minutes.The patient is stable and in hospital now.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/22/2018; batch # n5740x.The analysis results showed that the tlh30 device arrived with no apparent damage and with a reload present.The reload was received fully fired.The device was tested for functionality with a test reload and it fired and formed all the staples as intended.The device fired without any difficulties, the staples were noted to have a proper b-formation and the staple line was complete.The event described could not be confirmed as the device performed without any difficulties noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional information was requested and the following was obtained: is the patient still in the hospital? no.Was the extended hospital stay planned due to the type of procedure or patient pre-existing condition prior to the procedure? no.Was the patient's hospital stay extended due to the alleged issue with the device? no.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7247190
• Report Number: 3005075853-2018-07824
• Device Sequence Number: 894403
• Product Code: GDW
• UDI-Device Identifier: 20705036013225
• UDI-Public: 20705036013225
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• 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
• Report Date (Section B): 01/19/2018

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: 10/08/2021
• Device Catalogue Number: TLH30
• Device Lot Number: P4R57K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 63