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

Model Number 5DCS

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2017

Event Type  malfunction  

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 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.

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 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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 6809183
• MDR Text Key: 83225499
• Report Number: 0001056128-2017-00108
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: (01)00885825013288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1