MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number	5DCD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection of the jaws revealed that one of the jaws was broken.The device was inspected under magnification.Inspection of the damage area did not reveal any damage near the failure point on the jaws.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: - use error: too much force applied to the handle, - failure mode: damaged jaws, - environmental disturbances: damage due to shipping, handling, - grasping onto staples, clips, or other hard objects, - user incorrectly manipulates device through the trocar cannula, - poor fit of device into the trocar cannula causes user to exert excessive force during withdrawal.The instructions for use (ifu) state: - careful handling of instruments is necessary to avoid damage or breakage as a result of excessive force.- inspect the instrument for overall condition and physical integrity.Do not use the instrument if the insulation has been compromised or if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.- follow a suitable endoscopic surgery protocol.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the tip of the laparoscopic instrument broke off during the operation and had to be retrieved.The piece was retrieved using fluoroscopy and a grasper.The patient was not opened up.The surgical delay was approximately 1.5 ¿ 2 hours locating the broken piece.There was no patient injury reported.These are commonly used devices that are readily available.
Event or Problem Description
It was reported that the tip of the laparoscopic instrument broke off during the operation and had to be retrieved.The piece was retrieved using fluoroscopy and a grasper.The patient was not opened up.The surgical delay was approximately 1.5 ¿ 2 hours locating the broken piece.There was no patient injury reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
On (b)(6), 2017, stryker sustainability solutions (sss) received a complaint for a lap dissector device.The complaint device was returned, and investigation was completed on (b)(6), 2017, confirming the reported event.Malfunction mdrs have been filed for subsequent complaints in which the tip of a lap dissector device is completely detached.If the device was not returned but was alleged to have a completely detached tip, a malfunction mdr was also filed.After further analysis, stryker sustainability solutions will discontinue filing mdrs for lap accessory ¿ dissector tip completely detaching for the following reasons: ¿ since the initial mdr filing on (b)(6), 2017, there have been no additional reports of serious injury or surgical intervention to preclude serious injury or permanent impairment related to lap dissector device tip complete detachment.¿ the procedure related to the initial serious injury mdr was completed successfully.¿ the patient in the original mdr did not experience adverse consequences ¿ the most likely root cause of this malfunction is excessive force.The instructions for use (ifu) clearly state careful handling of instruments is necessary to avoid damage or breakage as a result of excessive force.Ifus can be downloaded at http://sustainability.Stryker.Com/ifu.¿ each customer communication letter recommends that product ifus be printed, reviewed, and readily available for operator reference during procedures when using our devices.¿ based on the post market data collected it was determined that the occurrence rate of the failure mode causing or contributing to a serious injury between the date range of (b)(6) 2017 ¿ (b)(6) 2020 was (b)(4) (1 mdr / 38958 shipped).Based on the analysis, the likelihood of the failure mode of lap accessory ¿ dissector tip completely detaching causing or contributing to another serious injury should the malfunction recur is considered remote.The reported event will continue to be monitored through post market surveillance.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 6833089
• Report Number: 0001056128-2017-00115
• Device Sequence Number: 717654
• Product Code: NUJ
• UDI-Device Identifier: 00885825013301
• UDI-Public: (01)00885825013301(17)191103(10)5231943
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012700
• 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): 03/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2019
• Device Model Number: 5DCD
• Device Catalogue Number: 5DCDRR
• Device Lot Number: 5231943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2016
• 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