MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS ETHICON ENDOPATH BABCOCK WITH RATCHET HANDLE; ETHICON ENDOPATH BABCOCK WITH HANDLE

Model Number 5BB

Device Problems Unknown (for use when the device problem is not known) (2204); Device Operates Differently Than Expected (2913)

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

Event Date 07/25/2017

Event Type  malfunction  

Event Description

Risk was notified that during a robotic assisted laparoscopic nissen's fundoplication the surgeon was using an ethicon endopath babcock with ratchet handle (5mm) (reprocessed per stryker), the surgeon assisting noticed the instrument would no longer unclamp.Babcock was clamped around the stomach at the time.Surgeon was able to force clamp open to release tissue.No harm occurred to the patient.Babcock removed from sterile field.Operating room director stated that the stryker sustainability rep came and picked up the device so it is not available to return from the hospital.Here is the equipment serial number reported to (b)(4): (b)(4).Patient discharged home (b)(6)2017.

• Brand Name: ETHICON ENDOPATH BABCOCK WITH RATCHET HANDLE
• Type of Device: ETHICON ENDOPATH BABCOCK WITH HANDLE
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 6797876
• MDR Text Key: 82984977
• Report Number: 6797876
• Device Sequence Number: 1
• Product Code: GCJ
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/07/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2020
• Device Model Number: 5BB
• Device Lot Number: 6177172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2017
• Distributor Facility Aware Date: 07/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR