MAUDE Adverse Event Report: STRYKER ENDOSCOPY J-HOOK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

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

Event Date 04/28/2016

Event Type  malfunction  

Event Description

During a lap appendectomy the relief scrub tech noticed a small piece broken off of the stryker flow j-hook sleeve.The stryker j-hook had been inserted into the patient before noticing.The scrub that started the case and that had put the stryker flow j-hook sleeve together didn't recall if it was broken.Doctor then searched inside the body cavity and irrigated.The piece was not seen in the fluid or the cavity.The suction canister was searched after and it was not found in there either.

• Brand Name: J-HOOK
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5300 region ct; lakeland FL 33815
• MDR Report Key: 5959453
• MDR Text Key: 55014297
• Report Number: 5959453
• Device Sequence Number: 1
• Product Code: GEI
• 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: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2016
• 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
• Patient Age: 36 YR