MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number CB5LT

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2014

Event Type  malfunction  

Event Description

It was reported that an unknown material was found in the cannula of the trocar prior to a procedure.The case was completed successfully.There was no medical treatment or intervention required and no adverse consequences associated with this event.

Event Description

It was reported that an unknown material was found in the cannula of the trocar prior to a procedure.The case was completed successfully.There was no medical treatment or intervention required and no adverse consequences associated with this event.

Manufacturer Narrative

An investigation has not yet been completed for this event.A supplemental report will be submitted once the investigation is complete.

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions (sss) for an evaluation.Examination of the returned device did not reveal evidence of clinical use.The plastic shaft was confirmed to be broken.The plastic was dented into the shaft making it impossible for an obturator to pass through the cannula shaft.Results of the investigation confirmed the reported issue as the device was received with a broken shaft.It is possible that the plastic shaft impacted a hard object with force beyond its validated parameters or experienced excessive lateral force.A review of the lot control sheet (lcs) indicated that all required inspections and tests were conducted on all devices in the lot in question indicating that the instrument was in working condition when released from stryker® sustainability solutions.The instructions for use instructions for use (ifu) states: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal." "do not use excessive force.".

• Brand Name: NA
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• 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: 4167796
• MDR Text Key: 5022321
• Report Number: 0001056128-2014-00120
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date: 09/16/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: CB5LT
• Device Catalogue Number: CB5LTRR
• Device Lot Number: 3085591
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2014
• 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