MAUDE Adverse Event Report: COOPERSURGICAL, INC. TIP T1920 LONG,STRL.W

Model Number 900212AA

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

Cracked around probe base.Fs log #(b)(4).1216677-2022-00200 tip t1920 long strl w 900212aa (b)(4).

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported conditon.

Manufacturer Narrative

Investigation: inspect returned samples.Analysis and findings: complaint (b)(4).Distribution history: this complaint unit was manufactured in 2009.The workorder number is not available and the original ship date is not known.Manufacturing record review: a review of the device history record could not be performed as the workorder number is not known.However, it should be noted at the time of manufacture, records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint amended accordingly.Incoming inspection review: not applicable.Service history record: no service history record found for this product.Historical complaint review: a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt: the complaint unit was returned on a repair.Visual evaluation: visual examination of the complaint unit revealed that the tip is separating at the braze joint.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: the most likely root cause is that the wrong cleaning agent was used by the customer.Corrective actions: the unit could not be repaired due to the type of failure.The customer will need to purchase a new tip.Coopersurgical will continue to monitor this complaint condition for trends.No further training required at this time.Was the complaint confirmed? yes.

Event Description

Cracked around probe base.Fs log # (b)(4).1216677-2022-00200-1 tip t1920 long strl w 900212aa e-complaint (b)(4).

• Brand Name: TIP T1920 LONG,STRL.W
• Type of Device: TIP T1920 LONG,STRL.W
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 14975532
• MDR Text Key: 304367191
• Report Number: 1216677-2022-00200
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900212AA
• Device Catalogue Number: 900212AA
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other