MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 90-S XL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0279351103

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that during hip arthroscopy, the tip of the electrode broke and got into the joint between the neck and joint capsule.According to the surgeon, the xray was used in order to locate the tip.As the surgeon applied anterior approach, it was not possible to reach the broken tip without taking a risk of damage to the ischiadic nerve, and without extension of the surgery time.As per the surgeon, at the moment the event was observed the surgery was taking 4 hours.According to the surgeon, the decision was made to leave the broken tip in the patient's body.Although there was patient involvement, the procedure was completed successfully.

Manufacturer Narrative

The product was not returned for investigation; therefore, the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: non-conforming component, poor assembly process, misuse.

Event Description

It was reported that during hip arthroscopy, the tip of the electrode broke and got into the joint between the neck and joint capsule.According to the surgeon, the xray was used in order to locate the tip.As the surgeon applied anterior approach, it was not possible to reach the broken tip without taking a risk of damage to the ischiadic nerve, and without extension of the surgery time.As per the surgeon, at the moment the event was observed the surgery was taking 4 hours.According to the surgeon, the decision was made to leave the broken tip in the patient's body.Although there was patient involvement, the procedure was completed successfully.

• Brand Name: 90-S XL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5321299
• MDR Text Key: 34239811
• Report Number: 0002936485-2015-01132
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K071859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0279351103
• Device Lot Number: 15238AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 75