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

Model Number	5DCS
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been 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.The device lot and serial numbers were not reported, therefore a review of the dhr was unable to be performed.The reported event could be attributed to: - user attempts to cut staples or clips, - user attempts to cut non-soft tissue, - user attempts to cut excessive amount of tissue.The instructions for use (ifu) state: - do not directly apply current to staples or clips.- instruments were designed for cutting soft tissue.Attempting to cut staples or clips may damage the instrument.- if cutting of staples or clips is attempted, damage to instrument may occur.A supplemental mdr will be submitted once the device evaluation is completed.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the laparoscopic scissors were dull.The laparoscopic scissors were replaced and there was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions after the initial mdr was filed.Visual inspection of the device showed signs of clinical use.The blades have debris present.The cautery pin was found to be damaged.Functional inspection revealed that the blade did provide a clean cut.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The updated investigation results confirm this incident no longer falls within mdr reportability requirements.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the laparoscopic scissors were dull.The laparoscopic scissors were replaced and there was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6809183
• Report Number: 0001056128-2017-00108
• Device Sequence Number: 13485314
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: (01)00885825013288
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110189
• 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): 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: 5DCS
• Device Catalogue Number: 5DCSRR
• Device Lot Number: 6128466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1