MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, ROTATING HANDLE, INSULATED SHAFT; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED GEI= ELECTROSURGICAL, CUTTIN

Catalog Number 0250080233

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/06/2017

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 there was a possible breach in insulation due to the peeling.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: the coating of the laparoscopic maryland forceps was found peeling off during the operation.There were 3 defected areas (0.5cm x 0.5cm) x2, (1cm x0.5cm) x1 the failure identified in the investigation is consistent with the complaint record.The probable root cause could be third party repair.Other potential root causes may include improper sterilization, rough handling during reprocessing, or user misuse.Mfg date: manufacture date is not known.(b)(4).

Event Description

It was reported that there was a possible breach in insulation due to the peeling.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: the coating of the laparoscopic maryland forceps was found peeling off during the operation.There were 3 defected areas (0.5cm x 0.5cm) x2, (1cm x0.5cm) x1 the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be third party repair.Mfg date: manufacture date is not known.(b)(4).

Event Description

It was reported that there was a possible breach in insulation due to the peeling.

• Brand Name: PKG, ROTATING HANDLE, INSULATED SHAFT
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED GEI= ELECTROSURGICAL, CUTTIN
• 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: roomi banerjee dua ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7073113
• MDR Text Key: 93610606
• Report Number: 0002936485-2017-01161
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K973259
• 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,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250080233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2017
• 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