MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS*45 ENDO LIN CUT RELOAD GR; STAPLE, IMPLANTABLE

Catalog Number	TR45G
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.We did not receive a valid batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.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.What stapler was used with the reported reload? what was the exact rectal procedure being performed? how many times was the device fired? were there any staple formation issues noted? were any difficulties experienced with device intraoperatively? were blood products required? what is the current patient status?.
Event or Problem Description
It was reported that the patient's rectal cancer.The patient had hematochezia after rectal cancer surgery, and was improved after intravenous drip of hemostatic drugs and repeated injection of sodium chloride, norepinephrine and hemocoagulase in anal canal.The patient is stable.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8757413
• Report Number: 3005075853-2019-20224
• Device Sequence Number: 2040164
• Product Code: GDW
• UDI-Device Identifier: 10705036003175
• UDI-Public: 10705036003175
• 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: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TR45G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR