MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ARTICULATING SCOPE, NTSC VERSION; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Catalog Number 0502110010

Device Problem Peeled/Delaminated (1454)

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

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that plastic tip of the device peeled off inside the patient.All the plastic was successfully retrieved from the patient.

Manufacturer Narrative

Alleged failure: tip of scope fell inside patient.Confirmed failure: ccd sensor replacement mishandling, cut viton repair mishandling.Probable root cause: manufacturing nonconformity; tear/cut in viton; scratch/obstruction on optics; loose thread on viton; rough / chipping surfaces; use error.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Mfg date: 10/30/2010.(b)(4).

Event Description

It was reported that plastic tip of the device peeled off inside the patient.All the plastic was successfully retrieved from the patient.

• Brand Name: ARTICULATING SCOPE, NTSC VERSION
• Type of Device: LAPAROSCOPE, GYNECOLOGIC (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: 5736982
• MDR Text Key: 48528412
• Report Number: 0002936485-2016-00565
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082451
• 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: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0502110010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2010
• 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