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

Model Number	CTI-512N
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.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 supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: excessive force.Contact of needle point with hard object.Shipping/handling damage or extreme conditions.The instructions for use (ifu) state: "before beginning the procedure, verify overall compatibility of all instruments and accessories." "inspect the instrument for overall condition and physical integrity.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.H3 other text : 81.
Event or Problem Description
It was reported the device hand piece broke while it was in the patient while the surgeon was closing the port site and that it was taken out under direct visualization.There was no further damage reported and x-ray was used to locate and retrieve all pieces.There was no other medical intervention reported and the complainant it not aware of the duration of extended procedure time.These are commonly used devices that are readily available.
Event or Problem Description
It was reported the device hand piece broke while it was in the patient while the surgeon was closing the port site and that it was taken out under direct visualization.There was no further damage reported and x-ray was used to locate and retrieve the pieces.There was no other medical intervention reported and the complainant it not aware of the duration of extended procedure time.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the returned complaint device, there was evidence of bio-burden on the device.The device was sent back broken into multiple pieces.At the top of the suture passers were the plunger pin and top thumb handle sits, the material was bent 90 degrees.The base handle with the 2 finger grips on the bottom the plastic was protruding outwards.There was a small fracture going around the corner.Most likely excessive force was applied to the handle while grasping causing the hand piece to break apart at the base.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: excessive force, contact of needle point with hard object, shipping/handling damage or extreme conditions, attempting to bend or otherwise alter the shape of the device/shaft.The instructions for use (ifu) state: "before beginning the procedure, verify overall compatibility of all instruments and accessories." "inspect the instrument for overall condition and physical integrity.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.

• 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: 18234581
• Report Number: 0001056128-2023-00027
• Device Sequence Number: 19627434
• Product Code: NLM
• UDI-Device Identifier: 00885825013318
• UDI-Public: 00885825013318
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K053585
• 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,Followup
• Report Date (Section B): 10/30/2024

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 Expiration Date: 09/05/2026
• Device Model Number: CTI-512N
• Device Catalogue Number: CTI-512NRR
• Device Lot Number: 15235500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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: Required Intervention
• Patient Sex: Unknown