MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC PROXIMATE; STAPLE, IMPLANTABLE

Model Number TX60B

Device Problems Failure to Deliver (2338); Failure to Form Staple (2579)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  malfunction  

Event Description

During case endo stapler (ethicon endo proximate reloadable linear stapler, ref.Tx60b 60mm, lot m4j185, expiration 08/31/2020) did not deliver staples or engage with omentum tissue.When stapler removed the omentum tissue, it retracted back into the abdomen and was unable to be seen.

• Brand Name: PROXIMATE
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; ml 120a; cincinnati OH 45242
• MDR Report Key: 6683850
• MDR Text Key: 78955883
• Report Number: 6683850
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: TX60B
• Device Catalogue Number: TX60B
• Device Lot Number: M4J185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.
• Patient Age: 33 YR