MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 2.5MM SCISSORS; ARTHROSCOPE

Catalog Number 0242100007

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device manufacture date is not known at this time.However, should it become available, it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported the grasper broke off inside of the patient.

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.Manufacture date is not known.(b)(4).

Event Description

It was reported the grasper broke off inside of the patient.

• Brand Name: 2.5MM SCISSORS
• Type of Device: ARTHROSCOPE
• 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: victoria milich ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6386261
• MDR Text Key: 69327226
• Report Number: 0002936485-2017-00264
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0242100007
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other