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

Model Number	H12LP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.The reported event could be attributed to: - excessive force applied - contact with hard object or other improper handling (contact with cautery instrument) - insufficient structural integrity - shipping/handling damage or extreme conditions post distribution from stryker's sustainability solutions.The instructions for use (ifu) state: - damage to the instrument can lead to patient injuries.Always inspect instrument carefully for overall integrity before use.- do not use excessive force.- careful handling of instruments is necessary to avoid damage or breakage.- 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.- a comprehensive understanding of the principles and techniques involved in laser, electrosurgical, and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments.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 hassan h12lp broke into pieces during surgery.As reported, the pieces were not retrieved.An x-ray was not used to locate the pieces and a larger incision was not made to retrieve the pieces.The surgery was delayed as the team had to replace the item and inflate the abdominal cavity again.There was no other patient injury or medical intervention reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
This supplemental report serves to correct the fda registration number to 0001056128.
Event or Problem Description
It was reported that the hassan h12lp broke into pieces during surgery.As reported, the pieces were not retrieved.An x-ray was not used to locate the pieces and a larger incision was not made to retrieve the pieces.The surgery was delayed as the team had to replace the item and inflate the abdominal cavity again.There was no other patient injury or medical intervention reported.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 received complaint device, the cannula housing was received in halves with top and bottom housing fragments of adhered to both portions of the housing.Adhesive was found to be present.The device inspection indicated that the complaint was confirmed for the reported failure mode.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.The reported event could be attributed to: - excessive force applied - contact with hard object or other improper handling - insufficient structural integrity - shipping/handling damage or extreme conditions post distribution from stryker's sustainability solutions.The instructions for use (ifu) state: - damage to the instrument can lead to patient injuries.Always inspect instrument carefully for overall integrity before use.- do not use excessive force.- careful handling of instruments is necessary to avoid damage or breakage.- 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.- a comprehensive understanding of the principles and techniques involved in laser, electrosurgical, and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the hassan h12lp broke into pieces during surgery.As reported, the pieces were not retrieved.An x-ray was not used to locate the pieces and a larger incision was not made to retrieve the pieces.The surgery was delayed as the team had to replace the item and inflate the abdominal cavity again.There was no other patient injury or medical intervention 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: 22006567
• Report Number: 0002090040-2025-00031
• Device Sequence Number: 13022323
• Product Code: NLM
• UDI-Device Identifier: 00885825014261
• UDI-Public: 00885825014261
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup,Followup
• Report Date (Section B): 08/11/2025

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: H12LP
• Device Catalogue Number: H12LP
• Device Lot Number: 16623425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 07/14/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/24/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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