MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, STRYKERFLOW ELECTROCAUTERY PROBE, J TIP, 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0250070442

Device Problem Break (1069)

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

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Mfg date: 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 the tip was broken during a procedure.It was also confirmed that all pieces were retrieved.

Event Description

It was reported that the tip was broken during a procedure.It was also confirmed that all pieces were retrieved.

Manufacturer Narrative

Alleged failure: tip fell off.Probable root cause: material/design error.Manufacturing/assembly error.Excessive user force.Severe shipping conditions.Disposable tip rubbing against product.User error.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

• Brand Name: PKG, STRYKERFLOW ELECTROCAUTERY PROBE, J TIP, 5MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8203586
• MDR Text Key: 131703816
• Report Number: 0002936485-2018-00734
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327051889
• UDI-Public: 07613327051889
• Combination Product (y/n): N
• PMA/PMN Number: K934094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250070442
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR