MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, NEEDLE HOLDER, CURVED LEFT; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250080341

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that an additional surgery was performed to remove a metallic layer from inside the patient.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: after end of surgery, when the nurse inspected device and found the metallic layer fall off from tc needle holder tip.The nurse reported this issue to surgeon immediately.At that time, the surgery has finished , the abdominal cavity has closed.After confirmed through x-ray, the metallic layer was found in patient¿s abdominal cavity.The patient performed the second surgery to take out metallic layer.Because of nurse discover this issue in time, the big medical accident wasn¿t happen.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be excessive contact with another surgical device and/or excessive reprocessing.Mfg date: manufacture date is not known.

Event Description

It was reported that an additional surgery was performed to remove a metallic layer from inside the patient.

• Brand Name: PKG, NEEDLE HOLDER, CURVED LEFT
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7802910
• MDR Text Key: 117797073
• Report Number: 0002936485-2018-00585
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 07613327058277
• UDI-Public: 07613327058277
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250080341
• Device Lot Number: 1540078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other