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

Model Number	CB12LT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
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 inspection 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, activated electrosurgical instrument melts part of device.The instructions for use (ifu) state: general: these instruments are only intended for use by individuals with adequate training and familiarity with minimally invasive techniques.For further information about techniques, complications and hazards, consult the medical literature.Minimally invasive instruments may differ in diameter from manufacturer to manufacturer.When minimally invasive instruments and accessories from different manufacturers are employed together, verify compatibility prior to initiation of the procedure.Become familiar with specific model of trocar and cannula prior to employing it in a surgical procedure to avoid damage to patient, to operator or to instrument.-before beginning the procedure, verify overall compatibility of all instruments and accessories.Breakage: 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.Trocar insertion/withdrawal: very little pressure may be required to complete entry once partial entry has been obtained.Excessive pressure could cause injury to the internal structures.The obturator is designed with the optical feature to minimize the risk of penetrating injury to intraabdominal and intra-thoracic structures.Observe standard precautionary measures for all obturator insertions.Establish the primary puncture site and using standard surgical procedure create an incision which allows the trocar to be introduced.Loss of control during entry may possibly result if the incision is inadequate, due to the increasing resistance of insertion and required penetration force.Insert the obturator through the incision using a 30º to 90º rotating motion.Apply continuous but controlled downward pressure on the obturator.¿ keep organs out of reach of trocar penetration by ensuring a suitable positioning of the patient¿s body.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the complaint will be reopened.
Event or Problem Description
It was reported the device sleeve splintered off into the patient.The visible pieces were retrieved during the case by picking them out.No larger incision was made to retrieve the pieces.Ultrasound was used to check for any remaining plastic left, but it was reported that this testing was not conclusive.The complainant is not aware of the duration of extended procedure time.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: 16834592
• Report Number: 0001056128-2023-00013
• Device Sequence Number: 3034270
• 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: K062497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: 04/29/2025
• Device Model Number: CB12LT
• Device Catalogue Number: CB12LTRR
• Device Lot Number: 13827008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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