MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 24FR 30° CUTTING LOOP ELECTRODE, .012 (6BX); HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 0504880400

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

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 that the electrode broke off in the patient and there was about a 10 minute delay.However, there was no patient injury and the broken loop was totally removed from the patient.

Manufacturer Narrative

The reported device was not received for investigation; therefore the reported failure cannot be confirmed.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 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: manufacturing/assembly error; severe shipping conditions; material/design error; use of incompatible instrumentation/hardware; damaged hardware/instrumentation; missing or damaged o-ring; improper cleaning/sterilization; user error with green light laser leading to component melting.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the electrode broke off in the patient and there was about a 10 minute delay.However, there was no patient injury and the broken loop was totally removed from the patient.

• Brand Name: 24FR 30° CUTTING LOOP ELECTRODE, .012 (6BX)
• Type of Device: HYSTEROSCOPE (AND 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: 5371762
• MDR Text Key: 36465360
• Report Number: 0002936485-2016-00069
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0504880400
• Device Lot Number: STRAN03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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