MAUDE Adverse Event Report: ETHICON INC. ETHICON SECURESTRAP OPEN; IMPLANTABLE STAPLE

Model Number	OPENSTRAP20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blood Loss (2597); Not Applicable (3189)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and the absorbable straps were used.It was reported that the sharp tracker edges caused patient bleeding from the fixation point, and the surgeon had to re-operate the patient.

• Brand Name: ETHICON SECURESTRAP OPEN
• Common Device Name: IMPLANTABLE STAPLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9604702
• Report Number: 2210968-2020-00520
• Device Sequence Number: 14072102
• Product Code: GDW
• UDI-Device Identifier: 10705031202757
• UDI-Public: 10705031202757
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123114
• 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
• Report Date (Section B): 12/21/2019

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 Model Number: OPENSTRAP20
• Device Catalogue Number: OPENSTRAP20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2019
• Initial Report FDA Received Date: 01/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention