MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG,STRYKEFLOW ELECROCAUTERY PROBE, SPATULA TIP, 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0250070441

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2017

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.(b)(4).

Event Description

It was reported that the insulation had been compromised.The procedure was completed successfully with a delay of few minutes.There are no reports of patient harm or adverse consequences.

Manufacturer Narrative

Alleged failure: compromised insulation.Probable root cause: power set too high, generator power malfunction, user misuse or overuse, material/design error, conductive irrigant used, improper use with another electromedical device.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Gtin: (b)(4).The device manufacturer date is not known.

Event Description

It was reported that the insulation had been compromised.The procedure was completed successfully with a delay of few minutes.There are no reports of patient harm or adverse consequences.

• Brand Name: PKG,STRYKEFLOW ELECROCAUTERY PROBE, SPATULA TIP, 5MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7083584
• MDR Text Key: 93872805
• Report Number: 0002936485-2017-01175
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934094
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250070441
• Device Lot Number: 15G0241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 04/20/2018
• 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