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

Model Number	OPENSTRAP20
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/09/2020.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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 ventral hernia repair on an unknown date in 2020 and the absorbable straps were used.It was reported that the handle was stuck in and the operating room staff was able to get it unstuck.It was also reported that after getting the device unstuck, the device was firing very rough and not tacking properly.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 07/20/2020 corrected information: d3, g1, g2 additional information: d4, d10, h4 h3 evaluation: the analysis results found that the device was returned with no damage in the external components.In addition, foil pouch was received.The instrument was disassembled; upon disassembly the strap advancer component was found bending damage that is why internal cannula components were not sliding properly and consequently the device did not work as intended and 9 straps were found inside cannula shaft.In addition, the ratchet pawl was found excessive wear and tear.No conclusion could be reached as to what may have caused the reported incident.

• 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: 9947479
• Report Number: 2210968-2020-02560
• Device Sequence Number: 11601678
• Product Code: GDW
• UDI-Device Identifier: 10705031202757
• UDI-Public: 10705031202757
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 06/30/2021
• Device Model Number: OPENSTRAP20
• Device Catalogue Number: OPENSTRAP20
• Device Lot Number: PH6986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/20/2020
• Patient Sequence Number: 1