MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number	CB12LT
Medical Device Problem Codes	Fracture (1260); Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation as the device is held at the facility for internal investigation.As the device was not returned for evaluation, inspection was unable to be performed.Additionally, as the complaint device was not returned, a conclusive root cause could not be determined and the reported event could not be confirmed.A review of the dhr could not be performed as the lot number was not reported.The device was unlikely to have been released from stryker with the reported failure mode based on our investigation.Therefore, the reported event could be attributed to: activated electrocautery instrument melts part of device.Excessive force applied.Contact with hard object or other improper handling.Insufficient structural integrity.Shipping/handling damage or extreme conditions.The instructions for use (ifu) state: inspect the instrument and package before opening.The contents of the package are sterile if the packaging has not been compromised.If the package is damaged or if it was opened and the instrument was not used, return the instrument and packaging to stryker sustainability solutions for resterilization by ethylene oxide (eto) gas.Inspect the instruments for any damage.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported that the trocar tip was broken and pieces still remain in patient.There was no medical intervention or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 19534163
• Report Number: 0001056128-2024-00066
• Device Sequence Number: 18245746
• Product Code: NLM
• UDI-Device Identifier: 00885825014438
• UDI-Public: 00885825014438
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CB12LT
• Device Catalogue Number: CB12LT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown