MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5MM 30° LAPAROSCOPE, AC; ARTHROSCOPE

Catalog Number 0502539030

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

It was reported that there was a missing chunk of the glass tip.

Manufacturer Narrative

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

Manufacturer Narrative

"the following repair diagnostic codes were identified: (1) ecp-a-otd (outer tube damage).(2) ecp-a-sid (moisture at distal end due to mishandling.This does confirm the alleged failure mode of [chunk of glass missing at the tip].Probable root cause: excessive force applied by user.Poor mate between cannula and scope.Poor fit between scope needle and cannula.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.       .

Event Description

It was reported that there was a missing chunk of the glass tip.

• Brand Name: 5MM 30° LAPAROSCOPE, AC
• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4306359
• MDR Text Key: 21338289
• Report Number: 0002936485-2014-00995
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0502539030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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